Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

Detailed Description
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Buprenorphine is a synthetic opioid analgesic with over twenty-five 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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A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Buprenorphine transdermal delivery system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee. receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs. Exclusion Criteria: receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics. Other protocol-specific exclusion/inclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine transdermal delivery system|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who were treated successfully for pain management |  |  | 
| a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain intensity and patient satisfaction scores |  |  | 
| Incidence of early discontinuation due to lack of efficacy |  |  | 
| Time to early discontinuation due to lack of efficacy |  |  | 
| Dose level at end of titration |  |  | 
| Investigator's assessment of therapeutic response |  |  | 
| Diary pain scores |  |  | 

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