Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Study Overview
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Brief Summary
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The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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 Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.

Conditions
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Osteoarthritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: osteoarthritis of the hip, knee, or spine for 1 year or longer. taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week. Exclusion Criteria: taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: BTDS 5<br>Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 5 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™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Adverse Events (AEs) as a Measure of Safety. | Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs). | Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, osteoarthritis, transdermal