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Trial record 89 of 663 for:    OXYCODONE

Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain

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ClinicalTrials.gov Identifier: NCT00463047
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : December 14, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Pain
Intervention Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Enrollment 323
Recruitment Details Subjects 18 to 80 years of age with chronic pain for at least 3 months, were opioid tolerant, on around-the-clock opioid therapy, with 1-4 breakthrough pain episodes a day were recruited from 46 centers in the United States. First participant screened: June 2007. Last participant last visit: February 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 Fentanyl Buccal Tablets (FBT) and immediate-release oxycodone. Subjects who did not titrate successfully 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 Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. 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. Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. 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 160 [1] 160
Completed 123 121
Not Completed 37 39
Reason Not Completed
Adverse Event             10             8
Lack of Efficacy             10             4
Lost to Follow-up             2             0
Non-compliance with study medication             3             5
Protocol Violation             5             5
Withdrawal by Subject             3             5
Non-compliance procedures             4             10
Not specified             0             2
[1]
323 subjects entered study period but 3 discontinued before being randomized to treatment
Period Title: Titration Period 2
Started 123 121
Completed 93 98
Not Completed 30 23
Reason Not Completed
Adverse Event             9             9
Lack of Efficacy             6             4
Withdrawal by Subject             1             0
Protocol Violation             2             3
Lost to Follow-up             1             2
Non-compliance study medication             4             2
Non-compliance procedures             4             1
Not specified             3             2
Period Title: Double-Blind Treatment Period 1
Started 96 [1] 94 [1]
Completed 93 90
Not Completed 3 4
Reason Not Completed
Adverse Event             0             2
Protocol Violation             1             2
Non-compliance with procedures             1             0
Not specified             1             0
[1]
After completion of titration period subjects were re-randomized to these two treatment arms
Period Title: Double-Blind Treatment Period 2
Started 93 90
Completed 92 88
Not Completed 1 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             1
Non-compliance with procedures             1             0
Arm/Group Title Total Number of Patients
Hide Arm/Group Description Fentanyl Buccal Tablets (FBT) and Immediate-Release Oxycodone crossover. The total number of patients (323) reflect the number that were enrolled to participate in the study prior to the first titration period. Three subjects withdrew before receiving any study drug so they are not listed as being assigned to either dosing arm in the titration studies, leaving only 320 subjects who were evenly divided between the two groups.
Overall Number of Baseline Participants 323
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants
<=18 years
0
   0.0%
Between 18 and 65 years
323
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 323 participants
50.2  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants
Female
188
  58.2%
Male
135
  41.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 323 participants
323
1.Primary Outcome
Title Pain Intensity Difference (PID15) At 15 Minutes
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 fifteen minutes after administration of 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 PI scores.
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.82  (0.07) 0.59  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 oxycodone (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 [Not Specified]
Method Mixed effects ANOVA
Comments Crossover analysis
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval 95%
0.18 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pain Intensity Difference (PID 5) at 5 Minutes
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 before and 5 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Episodes of breakthrough pain
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.08  (0.03) 0.05  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0081
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 0.03
Confidence Interval (2-Sided) 95%
0.01 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Pain Intensity Difference (PID 10) at 10 Minutes
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 before and 10 minutes after administration of 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 PI scores.
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.30  (0.04) 0.22  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 <0.0001
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 0.09
Confidence Interval (2-Sided) 95%
0.05 to 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pain Intensity Difference (PID 30) at 30 Minutes
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 before and 10 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.96  (0.09) 1.58  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 <0.0001
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 0.37
Confidence Interval 95%
0.30 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pain Intensity Difference (PID 45) at 45 Minutes
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 before and 45 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.87  (0.12) 2.59  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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%
0.20 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pain Intensity Difference (PID 60) at 60 Minutes
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 before and 60 minutes after administration of 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 PI scores.
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.35  (0.13) 3.19  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 <0.0001
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 0.17
Confidence Interval (2-Sided) 95%
0.08 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
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. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100.
Time Frame Immediately before and 5 minutes after administration of 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 PI scores.
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Mean (Standard Error)
Unit of Measure: Percent change in units on a scale
1.11  (0.45) 0.73  (0.37)
8.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes
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 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. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100.
Time Frame Immediately before and 10 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Mean (Standard Error)
Unit of Measure: Percentage change in units on a scale
4.08  (0.76) 3.16  (0.57)
9.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes
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. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100.
Time Frame Immediately before and 15 minutes after administration of 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 PI scores.
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Mean (Standard Error)
Unit of Measure: Percent change in units on a scale
11.40  (1.15) 8.59  (0.94)
10.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes
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. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100.
Time Frame Immediately before and 30 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Mean (Standard Error)
Unit of Measure: Percent change in units on a scale
27.83  (1.50) 23.06  (1.33)
11.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes
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. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100.
Time Frame Immediately before and 45 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Mean (Standard Error)
Unit of Measure: Percent change in units on scale
40.94  (1.76) 37.56  (1.57)
12.Secondary Outcome
Title Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes
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. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100.
Time Frame Immediately before and 60 minutes after study drug administration
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Mean (Standard Error)
Unit of Measure: Percent change in units on a scale
48.08  (1.85) 46.16  (1.75)
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.36  (0.13) 1.87  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.49
Confidence Interval 95%
0.39 to 0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.58  (0.34) 7.65  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.93
Confidence Interval (2-Sided) 95%
0.70 to 1.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Pain Relief (PR) Score at 5 Minutes
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 Five minutes after administration of 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.10  (0.43) 0.09  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1966
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 (PR) at 10 Minutes
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.30  (0.57) 0.25  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
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 (PR) at 15 Minutes
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.69  (0.74) 0.53  (0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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.
18.Secondary Outcome
Title Pain Relief Score (PR) at 30 Minutes
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.50  (0.83) 1.23  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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.
19.Secondary Outcome
Title Pain Relief Score (PR) at 45 Minutes
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.08  (0.80) 1.89  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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.
20.Secondary Outcome
Title Pain Relief Score (PR) at 60 Minutes
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.38  (0.76) 2.24  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
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 (TOTPAR60) at 60 Minutes
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1676 1687
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.32  (0.16) 5.63  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.69
Confidence Interval 95%
0.55 to 0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
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) times 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: Percent change in units on a scale
39.48  (15.67) 35.28  (14.27)
23.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes
Hide Description Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. 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 for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared.
Time Frame From time was administered to 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
48 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.3022
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5054
Confidence Interval (2-Sided) 95%
0.7 to 3.3
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment, <=10 Minutes
Hide Description The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. 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 for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
286 215
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0268
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4042
Confidence Interval (2-Sided) 95%
1.0 to 1.9
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment, <=15 Minutes
Hide Description The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. 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 for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
687 540
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0008
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4631
Confidence Interval (2-Sided) 95%
1.2 to 1.8
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment, <=30 Minutes
Hide Description The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. 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 for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
1259 1157
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0084
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3184
Confidence Interval (2-Sided) 95%
1.1 to 1.6
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment, <=45 Minutes
Hide Description The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. 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 for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
1499 1480
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.5283
Comments [Not Specified]
Method Generalize estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0788
Confidence Interval (2-Sided) 95%
0.9 to 1.4
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Time to Any Pain Relief (APR) by Treatment, <=60 Minutes
Hide Description The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. 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 for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
1559 1565
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.7110
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9491
Confidence Interval (2-Sided) 95%
0.7 to 1.3
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes
Hide Description Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). 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 for which the time to meaningful pain relief fell into 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
9 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.3288
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5355
Confidence Interval (2-Sided) 95%
0.2 to 1.9
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes
Hide Description The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
92 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.5145
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1485
Confidence Interval (2-Sided) 95%
0.8 to 1.7
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes
Hide Description The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
286 211
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0191
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4481
Confidence Interval (2-Sided) 95%
1.1 to 2.0
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes
Hide Description The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
787 636
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0006
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4396
Confidence Interval (2-Sided) 95%
1.2 to 1.8
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes
Hide Description The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
1179 1060
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.0044
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3426
Confidence Interval (2-Sided) 95%
1.1 to 1.6
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes
Hide Description The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes 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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
1359 1313
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.2184
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1448
Confidence Interval (2-Sided) 95%
0.9 to 1.4
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Standard Rescue Medication Usage
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 During the administration of study drug during the double blind treatment periods.
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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
144 131
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 0.5808
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9249
Confidence Interval (2-Sided) 95%
0.7 to 1.2
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Medication Performance Assessment 30 Minutes After-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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
Excellent 45 18
Very good 153 104
Good 533 343
Fair 450 566
Poor 334 489
No response 249 238
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 1.8908
Confidence Interval (2-Sided) 95%
1.7 to 2.2
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Medication Performance Assessment 60 Minutes After-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 Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Overall Number of Units Analyzed
Type of Units Analyzed: Breakthrough pain episodes
1764 1758
Measure Type: Number
Unit of Measure: Number of episodes treated
Excellent 158 101
Very good 562 424
Good 679 726
Fair 210 335
Poor 128 146
No response 27 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fentanyl Buccal Tablets (FBT), Immediate-Release Oxycodone
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 1.5841
Confidence Interval (2-Sided) 95%
1.4 to 1.8
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 After completion of both double-blind treatment periods or early termination
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Hide Analysis Population Description
Double-blind safety analysis set: 190 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment
Arm/Group Title Total
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Includes all patients who participated in the double-blind treatment period and completed treatment.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: Participants
Preferred Fentanyl Buccal Tablet (FBT) 99
Preferred Immediate-Release Oxycodone 63
No preference 15
Missing 13
39.Secondary Outcome
Title Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)
Hide Description The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented.
Time Frame The end of the first double-blind treatment period.
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Hide Analysis Population Description
Double-blind safety analysis set: 88 subjects who received FBT and 90 subjects who received Oxycodone in the first double-blind period
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 88 90
Measure Type: Number
Unit of Measure: Participants
Prior Medication 15 22
Study Medication 61 50
No Preference 12 18
40.Secondary Outcome
Title Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)
Hide Description The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented.
Time Frame At the end of the second double-blind treatment period (Visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind safety analysis set: 83 subjects who received FBT and 87 subjects who received Oxycodone in the second double-blind period
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 83 87
Measure Type: Number
Unit of Measure: Participants
Prior Medication 10 19
Study Medication 63 59
No Preference 10 9
41.Secondary Outcome
Title Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)
Hide Description The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented.
Time Frame Endpoint (End of second double-blind treatment period or last observation after start of treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind safety analysis set: 88 subjects who received FBT and 94 subjects who received Oxycodone at any time during the double-blind treatment period who completed the PFTS questionnaire
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. 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.
Overall Number of Participants Analyzed 183 183
Measure Type: Number
Unit of Measure: Participants
Prior Medication 11 19
Study Medication 66 63
No Preference 12 12
Time Frame Adverse events were monitored throughout the two titration periods and double-blind treatment periods. Each titration period was 7-10 days in length and each double-blind treatment period was 7-17 days. The average duration of treatment was 24.2 days.
Adverse Event Reporting Description 323 subjects were enrolled, 3 discontinued before receiving any study drug. 320 were randomized to titrate either FBT or oxycodone in first titration period. 36 received only FBT and discontinued (leaving 284 who received oxycodone), 39 received only oxycodone and discontinued leaving 281 who received FBT).
 
Arm/Group Title Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
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. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone. 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. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
All-Cause Mortality
Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/281 (0.36%)      0/284 (0.00%)    
Infections and infestations     
Pneumonia  1  1/281 (0.36%)  2 0/284 (0.00%)  0
Indicates events were collected by 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 1%
Fentanyl Buccal Tablets (FBT) Immediate-Release Oxycodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/281 (28.11%)      49/284 (17.25%)    
Gastrointestinal disorders     
Nausea * 1  26/281 (9.25%)  11/284 (3.87%) 
Diarrhea * 1  6/281 (2.14%)  3/284 (1.06%) 
Vomiting * 1  4/281 (1.42%)  3/284 (1.06%) 
Constipation * 1  1/281 (0.36%)  4/284 (1.41%) 
Dry mouth * 1  1/281 (0.36%)  3/284 (1.06%) 
Stomach discomfort * 1  3/281 (1.07%)  0/284 (0.00%) 
General disorders     
Application site pain * 1  13/281 (4.63%)  0/284 (0.00%) 
Application site ulcer * 1  11/281 (3.91%)  0/284 (0.00%) 
Fatigue * 1  2/281 (0.71%)  4/284 (1.41%) 
Application site erythema * 1  5/281 (1.78%)  0/284 (0.00%) 
Application site irritation * 1  8/281 (2.85%)  0/284 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  4/281 (1.42%)  3/284 (1.06%) 
Injury, poisoning and procedural complications     
Fall * 1  2/281 (0.71%)  3/284 (1.06%) 
Nervous system disorders     
Headache * 1  12/281 (4.27%)  8/284 (2.82%) 
Dizziness * 1  9/281 (3.20%)  2/284 (0.70%) 
Somnolence * 1  6/281 (2.14%)  5/284 (1.76%) 
Sedation * 1  3/281 (1.07%)  2/284 (0.70%) 
Psychiatric disorders     
Euphoric mood * 1  1/281 (0.36%)  3/284 (1.06%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  2/281 (0.71%)  7/284 (2.46%) 
Hyperhidrosis * 1  3/281 (1.07%)  1/284 (0.35%) 
*
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.
Results Point of Contact
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Name/Title: Medical Monitor
Organization: Cephalon, Inc.
Phone: 1-800-896-5855
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Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00463047     History of Changes
Other Study ID Numbers: C25608/3055/BP/MN
First Submitted: February 8, 2007
First Posted: April 19, 2007
Results First Submitted: February 26, 2010
Results First Posted: December 14, 2010
Last Update Posted: May 28, 2012