The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (BP96-0604)

August 27, 2012 updated by: Purdue Pharma LP

A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Phoenix Center for Clinical Research
      • Phoenix, Arizona, United States, 85023
        • Phoenix Orthopedic Center, Ltd.
    • Florida
      • Gainesville, Florida, United States, 32605
        • Gainesville Clinical Research Center
      • Miami, Florida, United States, 33134
        • SeaView Research
      • Plantation, Florida, United States, 33324
        • Park Place Therapeutic Center
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta Research Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research, P.C.
    • New Jersey
      • Linwood, New Jersey, United States, 08221
        • New Jersey Research Foundation
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research, Inc.
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Dallas, Texas, United States, 75235
        • Metroplex Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20
Drug: Placebo oxycodone/acetaminophen tablets
Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Drug: Placebo transdermal patch (TDS)
Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
Active Comparator: OXY/APAP
5 mg oxycodone/325 mg acetaminophen tablets
Drug: OXY/APAP
5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Experimental: BTDS
Buprenorphine transdermal patch 5, 10, or 20 mcg/hour
Drug: Buprenorphine transdermal patch
Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
Other Names:
  • Butrans™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
Time Frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
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.
On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
Time Frame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
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).
Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"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)
Time Frame: Day 84, or, if applicable, at early termination
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.
Day 84, or, if applicable, at early termination
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
Time Frame: Day 84
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.
Day 84
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
Time Frame: Day 84
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.
Day 84
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time Frame: Day 84
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.
Day 84
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time Frame: Day 84
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.
Day 84
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time Frame: Day 84
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.
Day 84
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
Time Frame: Day 84
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.
Day 84
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
Time Frame: Day 84
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.
Day 84
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
Time Frame: Day 84
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."
Day 84
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
Time Frame: Day 84
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."
Day 84
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
Time Frame: Day 84
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."
Day 84
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
Time Frame: Day 84
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."
Day 84
Time to Stable Pain Management
Time Frame: Start of study to day 21.
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).
Start of study to day 21.
The Time to Discontinuation Due to Lack of Efficacy
Time Frame: Time after dosing to dropout 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.
Time after dosing to dropout due to lack of efficacy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Primary Completion (Actual)

May 1, 1998

Study Completion (Actual)

May 1, 1998

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP96-0604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Back Pain

Clinical Trials on Placebo oxycodone/acetaminophen tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe