Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
FBT First Immediate Release Oxycodone Second	Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrate 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.
Immediate-Release Oxycodone First FBT Second	Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrate 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.

Participant Flow for 4 periods

Period 1:   Titration Period 1

	FBT First Immediate Release Oxycodone Second	Immediate-Release Oxycodone First FBT Second
STARTED	160 [1]	160
COMPLETED	123	121
NOT COMPLETED	37	39
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

Period 2:   Titration Period 2

	FBT First Immediate Release Oxycodone Second	Immediate-Release Oxycodone First FBT Second
STARTED	123	121
COMPLETED	93	98
NOT COMPLETED	30	23
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 3:   Double-Blind Treatment Period 1

	FBT First Immediate Release Oxycodone Second	Immediate-Release Oxycodone First FBT Second
STARTED	96 [1]	94 [1]
COMPLETED	93	90
NOT COMPLETED	3	4
Adverse Event	0	2
Lack of Efficacy	0	0
Protocol Violation	1	2
Non-compliance with procedures	1	0
Not specified	1	0

Period 4:   Double-Blind Treatment Period 2

	FBT First Immediate Release Oxycodone Second	Immediate-Release Oxycodone First FBT Second
STARTED	93	90
COMPLETED	92	88
NOT COMPLETED	1	2
Adverse Event	0	1
Withdrawal by Subject	0	1
Non-compliance with procedures	1	0

Reporting Groups

Description

Total Number of Patients

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.

Baseline Measures

	Total Number of Patients
Number of Participants   [units: participants]	323
Age   [units: participants]
<=18 years	0
Between 18 and 65 years	323
>=65 years	0
Age   [units: years] Mean ± Standard Deviation	50.2  ± 9.81
Gender   [units: participants]
Female	188
Male	135
Region of Enrollment   [units: participants]
United States	323

1.  Primary:

Pain Intensity Difference (PID15) At 15 Minutes   [ Time Frame: Immediately pre-dose and fifteen minutes after administration of study drug ]

2.  Secondary:

Pain Intensity Difference (PID 5) at 5 Minutes   [ Time Frame: Immediately before and 5 minutes after study drug administration ]

3.  Secondary:

Pain Intensity Difference (PID 10) at 10 Minutes   [ Time Frame: Immediately before and 10 minutes after administration of study drug ]

4.  Secondary:

Pain Intensity Difference (PID 30) at 30 Minutes   [ Time Frame: Immediately before and 10 minutes after study drug administration ]

5.  Secondary:

Pain Intensity Difference (PID 45) at 45 Minutes   [ Time Frame: Immediately before and 45 minutes after study drug administration ]

6.  Secondary:

Pain Intensity Difference (PID 60) at 60 Minutes   [ Time Frame: Immediately before and 60 minutes after administration of study drug ]

7.  Secondary:

Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment   [ Time Frame: Immediately before and 5 minutes after administration of study drug ]

8.  Secondary:

Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes   [ Time Frame: Immediately before and 10 minutes after study drug administration ]

9.  Secondary:

Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes   [ Time Frame: Immediately before and 15 minutes after administration of study drug ]

10.  Secondary:

Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes   [ Time Frame: Immediately before and 30 minutes after study drug administration ]

11.  Secondary:

Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes   [ Time Frame: Immediately before and 45 minutes after study drug administration ]

12.  Secondary:

Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes   [ Time Frame: Immediately before and 60 minutes after study drug administration ]

13.  Secondary:

Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)   [ Time Frame: From 5 minutes after dosing through 30 minutes after dosing ]

14.  Secondary:

Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)   [ Time Frame: From 5 minutes after dosing through 60 minutes after dosing ]

15.  Secondary:

Pain Relief (PR) Score at 5 Minutes   [ Time Frame: Five minutes after administration of study drug ]

16.  Secondary:

Pain Relief Score (PR) at 10 Minutes   [ Time Frame: 10 minutes after treatment with study drug ]

17.  Secondary:

Pain Relief Score (PR) at 15 Minutes   [ Time Frame: 15 minutes after treatment with study drug ]

18.  Secondary:

Pain Relief Score (PR) at 30 Minutes   [ Time Frame: 30 minutes after treatment with study drug ]

19.  Secondary:

Pain Relief Score (PR) at 45 Minutes   [ Time Frame: 45 minutes after treatment with study drug ]

20.  Secondary:

Pain Relief Score (PR) at 60 Minutes   [ Time Frame: 60 minutes after treatment with study drug ]

21.  Secondary:

Total Pain Relief (TOTPAR60) at 60 Minutes   [ Time Frame: From 5 minutes to 60 minutes after dosing ]

22.  Secondary:

Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)   [ Time Frame: From 5 minutes through 60 minutes after study drug treatment ]

23.  Secondary:

Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes   [ Time Frame: From time was administered to 5 minutes after treatment ]

24.  Secondary:

Time to Any Pain Relief (APR) by Treatment, <=10 Minutes   [ Time Frame: From study drug treatment until 10 minutes after treatment ]

25.  Secondary:

Time to Any Pain Relief (APR) by Treatment, <=15 Minutes   [ Time Frame: From study drug administration to 15 minutes after treatment ]

26.  Secondary:

Time to Any Pain Relief (APR) by Treatment, <=30 Minutes   [ Time Frame: Time of study drug administration till 30 minutes after treatment ]

27.  Secondary:

Time to Any Pain Relief (APR) by Treatment, <=45 Minutes   [ Time Frame: Time of study drug treatment until 45 minutes after treatment ]

28.  Secondary:

Time to Any Pain Relief (APR) by Treatment, <=60 Minutes   [ Time Frame: Time of study drug treatment until 60 minutes after treatment ]

29.  Secondary:

Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes   [ Time Frame: From time study drug was taken until 5 minutes after treatment ]

30.  Secondary:

Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes   [ Time Frame: Time of study drug treatment until 10 minutes after treatment ]

31.  Secondary:

Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes   [ Time Frame: Time of study drug administration until 15 minutes after treatment ]

32.  Secondary:

Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes   [ Time Frame: Time of study drug administration until 30 minutes after treatment ]

33.  Secondary:

Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes   [ Time Frame: From study drug administration until 45 minutes after treatment ]

34.  Secondary:

Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes   [ Time Frame: Time of study drug administration until 60 minutes after treatment ]

35.  Secondary:

Standard Rescue Medication Usage   [ Time Frame: During the administration of study drug during the double blind treatment periods. ]

36.  Secondary:

Medication Performance Assessment 30 Minutes After-treatment   [ Time Frame: 30 minutes post-treatment ]

37.  Secondary:

Medication Performance Assessment 60 Minutes After-treatment   [ Time Frame: 60 minutes post-treatment ]

38.  Secondary:

Breakthrough Pain Preference Questionnaire   [ Time Frame: After completion of both double-blind treatment periods or early termination ]

39.  Secondary:

Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)   [ Time Frame: The end of the first double-blind treatment period. ]

40.  Secondary:

Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)   [ Time Frame: At the end of the second double-blind treatment period (Visit 6) ]

41.  Secondary:

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)   [ Time Frame: Endpoint (End of second double-blind treatment period or last observation after start of treatment period) ]