Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Study Overview
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Brief Summary
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The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Official Title
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Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Conditions
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Osteoarthritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase. Exclusion Criteria: Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen. Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study. Refer to core study for additional inclusion/exclusion information.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTDS<br>Buprenorphine transdermal patch | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear<br>Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear<br>Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear<br>|

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 as a Measure of Safety and Tolerability | Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements. | 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Opioid, Transdermal