Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

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 Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Buprenorphine transdermal patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain. Exclusion Criteria: currently have condition requiring a stable regimen of acetaminophen (APAP). a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy. Other protocol-specific exclusion/inclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: BTDS10/20<br>Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4. | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch applied for 7-day wear.<br>* Other names: Butrans™;|
| Experimental: BTDS 20<br>Initial doses (Level 1) of BTDS 20. | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 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 Percentage of Subjects Who Completed the 14-day Double-blind Phase. | The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period). | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, opioid, transdermal