Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

Study Overview
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Brief Summary
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The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

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, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

Conditions
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Osteoarthritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer. an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment. Exclusion Criteria: ingest opioid analgesics on a daily basis. ingest >2500 milligrams (mg) acetaminophen on a daily basis. require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain. Other protocol-specific exclusion/inclusion criteria may apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTDS<br>Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h) | Drug: Buprenorphine transdermal patch<br>* Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.<br>* Other names: Butrans™;|
| Placebo Comparator: Placebo<br>Placebo to match BTDS 5, 10 or 20 mcg/h | Drug: Placebo<br>* Placebo to match BTDS 5, 10, or 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 Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. | Inadequate analgesia: average pain over the last 24 hours score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or; >1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or; ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia. | Double-blind phase ( 28 days): reaching inadequate analgesia on any 2 days of the 7-day dosing periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site | The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. Pain right now scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine). | 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. | 

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