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Trial record 76 of 665 for:    OXYCODONE

Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain

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ClinicalTrials.gov Identifier: NCT00813488
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : December 31, 2010
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Pain
Interventions Drug: Fentanyl Buccal Tablet
Drug: Immediate release oxycodone
Enrollment 213
Recruitment Details Subjects with chronic pain who had been receiving opioid therapy for the previous 7 days and reported on average 1 to 5 breakthrough pain episodes per day were recruited from 50 different study sites throughout the United States beginning December 2008 and completing in November 2009.
Pre-assignment Details Prior to the double-blind treatment period, subjects participated in two titration periods to identify a "successful" and tolerated dose of FBT and immediate-release oxycodone. Subjects who did not titrate to a successful and tolerated dose were excluded from further participation in the study.
Arm/Group Title FBT First Immediate Release Oxycodone Second Immediate-Release Oxycodone First FBT Second
Hide Arm/Group Description Subjects in this treatment group were assigned 200 mcg FBT during the first titration period and then 15 mg oxycodone during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized. Subjects in this treatment group were assigned 15 mg oxycodone during the first titration period and then 200 mcg FBT during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
Period Title: Titration Period 1
Started 107 106
Completed 80 89
Not Completed 27 17
Reason Not Completed
Adverse Event             6             1
Lack of Efficacy             9             7
Withdrawal by Subject             2             2
Protocol Violation             4             3
Non-compliance to study medication             4             1
Non-compliance to study procedures             2             2
Technical Difficulties             0             1
Period Title: Titration Period 2
Started 80 89
Completed 64 79
Not Completed 16 10
Reason Not Completed
Adverse Event             2             3
Lack of Efficacy             8             4
Protocol Violation             3             2
Lost to Follow-up             1             0
Non-compliance with study procedures             2             1
Period Title: Double-blind Treatment Period 1
Started 72 [1] 71 [1]
Completed 71 66
Not Completed 1 5
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             0             1
Protocol Violation             0             2
Lost to Follow-up             0             1
[1]
After titration subjects were re-randomized to these two treatment arms
Period Title: Double-blind Treatment Period 2
Started 71 66
Completed 66 65
Not Completed 5 1
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             1
Protocol Violation             2             0
Not Specified             1             0
Period Title: Open-label Extension
Started 65 [1] 66 [1]
Completed 53 [2] 59 [3]
Not Completed 12 7
Reason Not Completed
Adverse Event             1             2
Lack of Efficacy             3             0
Withdrawal by Subject             0             2
Protocol Violation             1             2
Non-compliance study medication             4             0
Non-compliance study procedures             2             1
Not specified             1             0
[1]
Patients completing double-blind periods were randomized to FBT or standard of care for open-label
[2]
This group received FBT open--label
[3]
This group received standard of care (including immediate-release oxycodone)
Arm/Group Title Total Number of Patients
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 213
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 213 participants
51.0  (9.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
Female
120
  56.3%
Male
93
  43.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
Hispanic or Latino
10
   4.7%
Not Hispanic or Latino
195
  91.5%
Unknown or Not Reported
8
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants
American Indian or Alaska Native
1
   0.5%
Asian
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
19
   8.9%
White
191
  89.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 213 participants
213
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 213 participants
30.1  (7.25)
1.Primary Outcome
Title Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame Immediately pre-dose and 15 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on scale
0.88  (0.09) 0.76  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed effects ANOVA crossover model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.06 to 0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pain Intensity Difference (PID) at 5 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame Immediately pre-dose and 5 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
.08  (.02) .06  (.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2242
Comments LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.01 to .05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Pain Intensity Difference (PID) at 10 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame Immediately pre-dose and 10 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
.35  (.05) .29  (.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0106
Comments LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
0.01 to .11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pain Intensity Difference (PID) at 30 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame Immediately pre-dose and 30 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.10  (0.12) 1.79  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
.21 to .40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pain Intensity Difference (PID) at 45 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame Immediately pre-dose and 45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.13  (0.14) 2.85  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.18 to .37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pain Intensity Difference (PID) at 60 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame Immediately pre-dose and 60 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.65  (0.15) 3.48  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.08 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time Frame Immediately pre-dose and 5 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
1.01  (4.50) 0.73  (3.02)
8.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period.
Time Frame Immediately before treatment and 10 minutes after treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
4.83  (11.21) 3.89  (8.30)
9.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time Frame Baseline (immediately pre-dose) and 15 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
12.38  (17.08) 10.38  (15.43)
10.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time Frame Pre-dose and 30 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
29.72  (21.30) 25.03  (20.42)
11.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time Frame Immediately pre-dose and 45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
44.84  (23.36) 40.49  (22.68)
12.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment
Hide Description Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.
Time Frame Immediately pre-dose and 60 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
52.61  (24.33) 49.47  (24.19)
13.Secondary Outcome
Title Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)
Hide Description PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Time Frame From 5 minutes after dosing through 30 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.54  (0.17) 2.16  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.25 to 0.50
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)
Hide Description

PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.

SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.

Time Frame From 5 minutes after dosing through 60 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.32  (0.44) 8.50  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
.55 to 1.10
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Pain Relief (PR) Score at 5 Minutes Post-treatment
Hide Description The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time Frame 5 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.11  (0.41) 0.10  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5575
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.
16.Secondary Outcome
Title Pain Relief Score at 10 Minutes Post-treatment
Hide Description The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time Frame 10 minutes after treatment with study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.32  (0.61) 0.26  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0981
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.
17.Secondary Outcome
Title Pain Relief Score at 15 Minutes Post-treatment
Hide Description The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time Frame 15 minutes after treatment with study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.68  (0.74) 0.56  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0443
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.
18.Secondary Outcome
Title Pain Relief Score at 30 Minutes Post-treatment
Hide Description The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time Frame 30 minutes after treatment with study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.48  (0.83) 1.22  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.
19.Secondary Outcome
Title Pain Relief Score at 45 Minutes Post-treatment
Hide Description The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time Frame 45 minutes after treatment with study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.14  (0.82) 1.90  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.
20.Secondary Outcome
Title Pain Relief Score at 60 Minutes Post-treatment
Hide Description The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Time Frame 60 minutes after treatment with study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.44  (0.83) 2.27  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.
21.Secondary Outcome
Title Total Pain Relief at 60 Minutes (TOTPAR60)
Hide Description

The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:

TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.

Time Frame From 5 minutes to 60 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1335 1324
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6.43  (0.20) 5.70  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.74
Confidence Interval 95%
0.58 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)
Hide Description The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.
Time Frame From 5 minutes through 60 minutes after study drug treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Mean (Standard Deviation)
Unit of Measure: Percentage change
40.11  (16.32) 35.59  (15.78)
23.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes
Hide Description Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared.
Time Frame From time study drug was taken until 5 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
55 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7012
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1464
Confidence Interval (2-Sided) 95%
0.6 to 2.3
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment <=10 Minutes
Hide Description Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared.
Time Frame From study drug treatment until 10 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
226 219
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6545
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0704
Confidence Interval (2-Sided) 95%
0.8 to 1.4
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment <=15 Minutes
Hide Description Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared.
Time Frame From study drug administration to 15 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
515 451
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0407
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2544
Confidence Interval (2-Sided) 95%
1.0 to 1.6
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment <=30 Minutes
Hide Description Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared.
Time Frame Time of study drug administration till 30 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
1004 877
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5745
Confidence Interval (2-Sided) 95%
1.2 to 2.0
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment <=45 Minutes
Hide Description Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared.
Time Frame Time of study drug treatment until 45 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
1217 1150
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0372
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5828
Confidence Interval (2-Sided) 95%
1.0 to 2.4
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment <=60 Minutes
Hide Description Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared.
Time Frame Time of study drug treatment until 60 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
1271 1239
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3099
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3722
Confidence Interval (2-Sided) 95%
0.7 to 2.5
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes
Hide Description Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared.
Time Frame From time study drug was taken until 5 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
21 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5777
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8434
Confidence Interval (2-Sided) 95%
.5 to 1.5
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes
Hide Description Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared.
Time Frame Time of study drug treatment until 10 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
88 91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9567
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9860
Confidence Interval (2-Sided) 95%
0.6 to 1.6
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes
Hide Description Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared.
Time Frame Time of study drug administration until 15 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
230 212
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4253
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1366
Confidence Interval (2-Sided) 95%
0.8 to 1.6
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes
Hide Description Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared.
Time Frame Time of study drug administration until 30 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
613 503
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4269
Confidence Interval (2-Sided) 95%
1.1 to 1.8
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes
Hide Description Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared.
Time Frame From study drug administration until 45 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
983 864
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5118
Confidence Interval 95%
1.2 to 1.9
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes
Hide Description Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared.
Time Frame Time of study drug administration until 60 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
1139 1047
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5826
Confidence Interval (2-Sided) 95%
1.1 to 2.2
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Use of Standard Rescue Medication
Hide Description Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.
Time Frame Throughout the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
39 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8444
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0590
Confidence Interval (2-Sided) 95%
0.6 to 1.9
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Medication Performance Assessment 30 Minutes Post-treatment
Hide Description The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.
Time Frame 30 minutes post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
Excellent 49 16
Very Good 125 104
Good 378 304
Fair 416 391
Poor 341 489
No Response 33 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6033
Confidence Interval (2-Sided) 95%
1.4 to 1.8
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Medication Performance Assessment 60 Minutes Post-treatment
Hide Description The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.
Time Frame 60 minutes post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Immediate-release Oxycodone (OXY)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.

Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period.

Overall Number of Participants Analyzed 137 137
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1342 1334
Measure Type: Number
Unit of Measure: Episodes
Excellent 160 119
Very Good 371 313
Good 508 565
Fair 181 179
Poor 92 136
No Response 30 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablet (FBT), Immediate-release Oxycodone (OXY)
Comments Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3334
Confidence Interval (2-Sided) 95%
1.2 to 1.5
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Breakthrough Pain Preference Questionnaire
Hide Description The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.
Time Frame At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind safety analysis set: 143 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment
Arm/Group Title Total
Hide Arm/Group Description:

Includes all patients who participated in the double-blind treatment period and completed treatment.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Overall Number of Participants Analyzed 143
Measure Type: Number
Unit of Measure: Participants
Preferred FBT 62
Preferred Oxycodone 46
No Preference 23
Missing 12
39.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment
Hide Description The PGIC is a standardized self-report tool that measures the change in a patient’s overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= –3, much worse= –2, minimally worse= –1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period.
Time Frame One month after start of open-label treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 55 61
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
1.5  (0.88) 0.6  (0.99)
40.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment
Hide Description The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period.
Time Frame 2 months after start of open-label extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 54 60
Mean (Standard Deviation)
Unit of Measure: Units on scale
1.5  (0.99) 0.8  (0.99)
41.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment
Hide Description The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period.
Time Frame 3 months after start of open-label extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 53 59
Mean (Standard Deviation)
Unit of Measure: Units on scale
1.7  (0.86) 0.8  (1.09)
42.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Endpoint
Hide Description The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period.
Time Frame At conclusion of open-label extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.5  (1.02) 0.9  (1.09)
43.Secondary Outcome
Title Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment
Hide Description

The CGIC is a standardized tool that measures the change in a patient’s overall status rating since the start of the open-label extension period, in the opinion of the clinician.

The 7-point scale includes very much worse=–3, much worse=–2, minimally worse=–1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period.

Time Frame One month after start of open-label extension
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 57 63
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
1.4  (0.79) 0.6  (0.91)
44.Secondary Outcome
Title Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment
Hide Description

The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.

The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.

The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination).

Time Frame Two months after start of open-label extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 54 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.4  (0.96) 0.7  (0.88)
45.Secondary Outcome
Title Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment
Hide Description

The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.

The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period.

Time Frame 3 months after start of open-label extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 53 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.6  (0.81) 0.7  (1.02)
46.Secondary Outcome
Title Clinician Global Impression of Change (CGIC)Endpoint
Hide Description

The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.

The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination).

Time Frame End of open-label extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.
Arm/Group Title Fentanyl Buccal Tablet (FBT) Standard of Care (SOC)
Hide Arm/Group Description:

FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.

Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.

During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period.

Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
Overall Number of Participants Analyzed 65 65
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.4  (1.01) 0.7  (1.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fentanyl Buccal Tablet Oxycodone Standard of Care
Hide Arm/Group Description This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period. 213 subjects began the first titration period and of those 17 discontinued before exposure to FBT. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 196 subjects had exposure to FBT This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period (they were only exposed to one drug). 213 subjects began the first titration period and of those 27 discontinued before exposure to oxycodone. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 186 subjects had exposure to oxycodone 21 subjects received standard of care analgesics apart from oxycodone or FBT during the Open-Label Extension Period. Subjects who took oxycodone during SOC are listed under Oxycodone.
All-Cause Mortality
Fentanyl Buccal Tablet Oxycodone Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl Buccal Tablet Oxycodone Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/196 (2.04%)      3/186 (1.61%)      1/21 (4.76%)    
Cardiac disorders       
Cyanosis * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Myocardial infarction * 1  0/196 (0.00%)  0 1/186 (0.54%)  1 0/21 (0.00%)  0
Gastrointestinal disorders       
Oesophageal mass * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Vomiting * 1  0/196 (0.00%)  0 0/186 (0.00%)  0 1/21 (4.76%)  1
General disorders       
Chest pain * 1  0/196 (0.00%)  0 1/186 (0.54%)  1 0/21 (0.00%)  0
Drug withdrawal syndrome * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations       
Cystitis * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Sepsis syndrome * 1  0/196 (0.00%)  0 0/186 (0.00%)  0 1/21 (4.76%)  1
Investigations       
Blood creatinine increased * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/196 (0.00%)  0 0/186 (0.00%)  0 1/21 (4.76%)  1
Malnutrition * 1  0/196 (0.00%)  0 0/186 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders       
Unresponsive to stimuli * 1  1/196 (0.51%)  1 1/186 (0.54%)  1 0/21 (0.00%)  0
Syncope * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders       
Renal failure acute * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Hypoxia * 1  1/196 (0.51%)  1 0/186 (0.00%)  0 0/21 (0.00%)  0
Pneumonia aspiration * 1  0/196 (0.00%)  0 0/186 (0.00%)  0 1/21 (4.76%)  1
Pulmonary embolism * 1  0/196 (0.00%)  0 1/186 (0.54%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fentanyl Buccal Tablet Oxycodone Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/196 (22.96%)      42/186 (22.58%)      8/21 (38.10%)    
Gastrointestinal disorders       
Nausea * 1  9/196 (4.59%)  7/186 (3.76%)  0/21 (0.00%) 
Vomiting * 1  6/196 (3.06%)  5/186 (2.69%)  1/21 (4.76%) 
Constipation * 1  3/196 (1.53%)  1/186 (0.54%)  2/21 (9.52%) 
Infections and infestations       
Urinary tract infection * 1  3/196 (1.53%)  4/186 (2.15%)  2/21 (9.52%) 
Influenza * 1  3/196 (1.53%)  2/186 (1.08%)  2/21 (9.52%) 
Injury, poisoning and procedural complications       
Fall * 1  1/196 (0.51%)  2/186 (1.08%)  2/21 (9.52%) 
Investigations       
Liver function test abnormal * 1  0/196 (0.00%)  0/186 (0.00%)  2/21 (9.52%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  8/196 (4.08%)  8/186 (4.30%)  2/21 (9.52%) 
Nervous system disorders       
Somnolence * 1  9/196 (4.59%)  9/186 (4.84%)  0/21 (0.00%) 
Headache * 1  8/196 (4.08%)  6/186 (3.23%)  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All unpublished information given to an investigator by Cephalon shall not be published or disclosed to a third party without the prior written consent of Cephalon.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sponsor's Medical Expert, Clinical Research
Organization: Cephalon, Inc.
Phone: 1-800-896-5855
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00813488     History of Changes
Other Study ID Numbers: C25608/3056/BP/US
First Submitted: December 19, 2008
First Posted: December 23, 2008
Results First Submitted: August 31, 2010
Results First Posted: December 31, 2010
Last Update Posted: May 28, 2012