Trial Outcomes & Findings for The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (NCT NCT00315445)

Results Overview

Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

134 participants

Primary outcome timeframe

On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

Results posted on

2012-09-03

Participant Flow

10-Dec-1997 (first subject, first visit) to 08-May-1998 (last subject last visit) in 13 centers in the United States

This study was designed to evaluate the efficacy and safety of BTDS in comparison with current pharmacotherapeutic pain management practice and placebo in opioid-naïve or opioid-experienced adult subjects with chronic back pain not manageable with nonopioid analgesics alone (range, 19-85 years).

Participant milestones

Participant milestones
Measure	Placebo Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Overall Study STARTED	45	43	46
Overall Study COMPLETED	18	27	22
Overall Study NOT COMPLETED	27	16	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Overall Study Adverse Event	7	12	15
Overall Study Lack of Efficacy	16	1	7
Overall Study Lost to Follow-up	1	0	1
Overall Study Protocol Violation	2	0	1
Overall Study Other	1	3	0

Baseline Characteristics

The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=43 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.	Total n=134 Participants Total of all reporting groups
Age Continuous	52 years STANDARD_DEVIATION 2.2 • n=5 Participants	49 years STANDARD_DEVIATION 2.5 • n=7 Participants	54 years STANDARD_DEVIATION 2.2 • n=5 Participants	52 years STANDARD_DEVIATION 1.31 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	80 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	54 Participants n=4 Participants
Opioid Experience Opioid naive	39 participants n=5 Participants	34 participants n=7 Participants	34 participants n=5 Participants	107 participants n=4 Participants
Opioid Experience Opioid experienced	6 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants	27 participants n=4 Participants

PRIMARY outcome

Timeframe: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

Population: All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])	-1.01 Units on a scale Standard Error 0.37	-1.82 Units on a scale Standard Error 0.36	-1.92 Units on a scale Standard Error 0.34

PRIMARY outcome

Timeframe: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Pain right now is presented as the LSmean \[change from baseline\] (SE).

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)	-0.80 Units on a scale Standard Error 0.38	-1.53 Units on a scale Standard Error 0.37	-1.66 Units on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: Day 84, or, if applicable, at early termination

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. "Physical Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)	46.4 Units on a scale Standard Error 4.0	44.5 Units on a scale Standard Error 3.9	46.5 Units on a scale Standard Error 3.6

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. "Physical Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)	18.9 Units on a scale Standard Error 4.8	24.4 Units on a scale Standard Error 5.9	33.9 Units on a scale Standard Error 5.8

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Bodily Pain" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)	35.3 Units on a scale Standard Error 3.1	39.0 Units on a scale Standard Error 3.4	41.9 Units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "General Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	52.4 Units on a scale Standard Error 3.5	52.5 Units on a scale Standard Error 3.5	57.7 Units on a scale Standard Error 3.4

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Vitality" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	39.0 Units on a scale Standard Error 3.7	42.9 Units on a scale Standard Error 3.7	41.2 Units on a scale Standard Error 3.5

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Social Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	53.3 Units on a scale Standard Error 4.2	59.5 Units on a scale Standard Error 3.9	65.2 Units on a scale Standard Error 4.4

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Emotional Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)	55.3 Units on a scale Standard Error 6.7	56.3 Units on a scale Standard Error 7.1	63.0 Units on a scale Standard Error 6.2

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Mental Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)	67.4 Units on a scale Standard Error 3.1	68.8 Units on a scale Standard Error 2.7	67.8 Units on a scale Standard Error 3.3

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=34 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=34 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)	1.1 Units on a scale Standard Error 0.2	2.0 Units on a scale Standard Error 0.2	1.9 Units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=34 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=33 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)	1.1 Units on a scale Standard Error 0.2	2.1 Units on a scale Standard Error 0.1	2.0 Units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = "Worse than prestudy medicine" to 2 = "Better than prestudy medicine."

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=34 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=33 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)	0.9 Units on a scale Standard Error 0.1	1.4 Units on a scale Standard Error 0.1	1.4 Units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=34 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=33 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)	2.2 Units on a scale Standard Error 0.1	1.8 Units on a scale Standard Error 0.1	1.7 Units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Start of study to day 21.

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

For each subject, "time to stable pain management" is defined as the first (post-baseline) time during the titration period when his/her "diary pain" was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the "pain on the average" (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline).

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Time to Stable Pain Management	14 Days Interval 4.0 to NA because less than 75% of placebo subjects achieved stable pain management.	7 Days Interval 4.0 to 13.0	7 Days Interval 4.0 to 18.0

SECONDARY outcome

Timeframe: Time after dosing to dropout due to lack of efficacy

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data.

Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P\< .10, using a backward elimination procedure.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
The Time to Discontinuation Due to Lack of Efficacy	NA Days Interval 21.0 to NA because few subjects (16 in the placebo group) experienced lack of efficacy during the study.	NA Days NA because few subjects (1 in the OXY/APAP group) experienced lack of efficacy during the study.	NA Days NA because few subjects (7 in the BTDS group) experienced lack of efficacy during the study.

POST_HOC outcome

Timeframe: Baseline to days 21 - 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Sensitivity Analysis: "Pain on the Average" Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)	-0.77 Units on a scale Standard Error 0.38	-1.70 Units on a scale Standard Error 0.38	-1.74 Units on a scale Standard Error 0.35

POST_HOC outcome

Timeframe: Baseline to days 21-84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Primary back pain was measured.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Sensitivity Analysis: "Pain Right Now" Change From Baseline in the Maintenance Period (Days 21-84), BOCF	-0.53 Units on a scale Standard Error 0.37	-1.46 Units on a scale Standard Error 0.37	-1.64 Units on a scale Standard Error 0.33

POST_HOC outcome

Timeframe: Baseline to days 21-84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it. This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation).

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Sensitivity Analysis "Pain on the Average" Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)	-0.91 Units on a scale Standard Error 0.39	-1.77 Units on a scale Standard Error 0.39	-1.86 Units on a scale Standard Error 0.35

POST_HOC outcome

Timeframe: Baseline to days 21-84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Sensitivity Analysis: "Pain Right Now" Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)	-0.78 Units on a scale Standard Error 0.38	-1.60 Units on a scale Standard Error 0.38	-1.59 Units on a scale Standard Error 0.34

POST_HOC outcome

Timeframe: Baseline to day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it. This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation).

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Sensitivity Analysis: "Pain on the Average" Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)	-1.44 Units on a scale Standard Error 0.44	-1.47 Units on a scale Standard Error 0.44	-1.70 Units on a scale Standard Error 0.40

POST_HOC outcome

Timeframe: Baseline to day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded. Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=42 Participants 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 Participants Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
Sensitivity Analysis: "Pain Right Now" Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)	-1.30 Units on a scale Standard Error 0.45	-1.56 Units on a scale Standard Error 0.45	-1.50 Units on a scale Standard Error 0.41

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

OXY/APAP

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

BTDS

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=45 participants at risk Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.	OXY/APAP n=43 participants at risk 5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.	BTDS n=46 participants at risk Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
General disorders Chest pain	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.3% 1/43 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/46 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Investigations Fractured humerous	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.3% 1/43 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/46 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
General disorders Increased back pain	2.2% 1/45 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/43 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/46 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Cardiac disorders Syncope	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/43 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.2% 1/46 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Gastrointestinal disorders Diverticulitis	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/43 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.2% 1/46 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Gastrointestinal disorders Bowel obstruction	2.2% 1/45 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/43 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/46 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Renal and urinary disorders Obstructed right kidney	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.3% 1/43 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/46 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Renal and urinary disorders Pyelonephritis	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.3% 1/43 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/46 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/45 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	0.00% 0/43 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.	2.2% 1/46 • Number of events 1 • All adverse events (AEs) were followed until resolved or etiology diagnosed. Deaths, adverse events and discontinuations occurring more than 7 days after discontinuation of study medication were reported. AEs were learned of by spontaneous reports, subject interview, and daily diary.

Other adverse events

Additional Information

Medical Director

Purdue Pharma L.P.

Phone: 800-733-1333

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60