Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
August 27, 2012 updated by: Purdue Pharma LP
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.
Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
Study Overview
Status
Terminated
Conditions
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 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)
10
Phase
- Phase 2
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
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Arizona
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Phoenix, Arizona, United States, 85023
- Arizona Research Center
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California
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San Clemente, California, United States, 92672
- Accurate Clinical Trials, Inc
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Florida
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Orlando, Florida, United States, 32804
- Southeastern Clinical Research Consultants
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Maryland
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Baltimore, Maryland, United States, 21218
- Greater Chesapeake Orthopaedic Associates
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Pennsylvania
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Sewickley, Pennsylvania, United States, 15143
- Sewickley Valley Hospital
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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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
- Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.
Exclusion Criteria:
- Subjects who have pain or disability in a site other than the operative joint.
- Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
- Subjects whose body mass index (BMI) is 40 or more.
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 |
|---|---|
|
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Other Names:
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Other Names:
Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
Other Names:
|
|
Experimental: BTDS 10
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
|
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Other Names:
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Other Names:
Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
Other Names:
|
|
Experimental: BTDS 30
Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear
|
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Other Names:
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Other Names:
Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.
Other Names:
|
|
Placebo Comparator: Placebo TDS
Placebo patches were similar to BTDS 10 and 20.
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Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time Frame: From signed informed consent to 7 days after end of study (approx. 35 days)
|
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
|
From signed informed consent to 7 days after end of study (approx. 35 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
November 21, 2006
First Submitted That Met QC Criteria
November 22, 2006
First Posted (Estimate)
November 23, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUP2003
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