Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Buprenorphine transdermal patch
* Drug: Buprenorphine transdermal patch
* Drug: Buprenorphine transdermal patch
* Drug: Placebo BTDS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTDS 10<br>Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.<br>* Other names: Butrans™;|
| Experimental: BTDS 20<br>Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.<br>* Other names: Butrans™;|
| Experimental: BTDS 30<br>Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.<br>* Other names: Butrans™;|
| Placebo Comparator: Placebo TDS<br>Placebo patches were similar to BTDS 10 and 20. | Drug: Placebo BTDS<br>* Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, opioid, transdermal, TKA (total knee arthroplasty)