Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Study Overview
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Brief Summary
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The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

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, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: 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
* Drug: Buprenorphine transdermal patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase. Exclusion Criteria: Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase. 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

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
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 transdermally for 7-day wear.<br>* Other names: Butrans™;Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear.<br>* Other names: Butrans™;Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 20 mcg/h applied transdermally 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 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. | 52 weeks | 

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