Back to resultsThe Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (BP96-0604)
Primary Purpose
Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal patch
Placebo oxycodone/acetaminophen tablets
OXY/APAP
Placebo transdermal patch (TDS)
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring chronic back pain, opioid, transdermal
Eligibility Criteria
Inclusion Criteria: clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions. unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day. Exclusion Criteria: receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products. scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period. Other protocol-specific exclusion/inclusion criteria may apply.
Sites / Locations
- Rheumatology Associates of North Alabama
- Phoenix Center for Clinical Research
- Phoenix Orthopedic Center, Ltd.
- Gainesville Clinical Research Center
- SeaView Research
- Park Place Therapeutic Center
- Atlanta Research Center
- The Center for Pharmaceutical Research, P.C.
- New Jersey Research Foundation
- North Carolina Clinical Research, Inc.
- Research Across America
- Metroplex Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo
OXY/APAP
BTDS
Arm Description
Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20
5 mg oxycodone/325 mg acetaminophen tablets
Buprenorphine transdermal patch 5, 10, or 20 mcg/hour
Outcomes
Primary Outcome Measures
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
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.
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
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).
Secondary Outcome Measures
"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)
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.
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
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.
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
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.
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
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.
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
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.
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
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.
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
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.
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
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.
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
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."
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
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."
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
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."
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
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."
Time to Stable Pain Management
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).
The Time to Discontinuation Due to Lack of Efficacy
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00315445
Brief Title
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Acronym
BP96-0604
Official Title
A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
May 1998 (Actual)
Study Completion Date
May 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Purdue Pharma LP
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
chronic back pain, opioid, transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20
Arm Title
OXY/APAP
Arm Type
Active Comparator
Arm Description
5 mg oxycodone/325 mg acetaminophen tablets
Arm Title
BTDS
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 5, 10, or 20 mcg/hour
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Placebo oxycodone/acetaminophen tablets
Intervention Description
Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Intervention Type
Drug
Intervention Name(s)
OXY/APAP
Intervention Description
5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal patch (TDS)
Intervention Description
Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
Primary Outcome Measure Information:
Title
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
Description
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.
Time Frame
On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Title
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
Description
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).
Time Frame
Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Secondary Outcome Measure Information:
Title
"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)
Description
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.
Time Frame
Day 84, or, if applicable, at early termination
Title
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
Description
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.
Time Frame
Day 84
Title
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
Description
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.
Time Frame
Day 84
Title
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Description
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.
Time Frame
Day 84
Title
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Description
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.
Time Frame
Day 84
Title
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Description
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.
Time Frame
Day 84
Title
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Description
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.
Time Frame
Day 84
Title
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
Description
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.
Time Frame
Day 84
Title
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
Description
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."
Time Frame
Day 84
Title
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
Description
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."
Time Frame
Day 84
Title
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
Description
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."
Time Frame
Day 84
Title
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
Description
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."
Time Frame
Day 84
Title
Time to Stable Pain Management
Description
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).
Time Frame
Start of study to day 21.
Title
The Time to Discontinuation Due to Lack of Efficacy
Description
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.
Time Frame
Time after dosing to dropout due to lack of efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.
Exclusion Criteria:
receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.
Other protocol-specific exclusion/inclusion criteria may apply.
Facility Information:
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Phoenix Center for Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Phoenix Orthopedic Center, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Gainesville Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
SeaView Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Park Place Therapeutic Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Atlanta Research Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
The Center for Pharmaceutical Research, P.C.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
New Jersey Research Foundation
City
Linwood
State/Province
New Jersey
ZIP/Postal Code
08221
Country
United States
Facility Name
North Carolina Clinical Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information
Learn more about this trial
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
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