Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

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 (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) 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 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.

Official Title
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Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Buprenorphine
* Drug: Buprenorphine
* Drug: oxycodone immediate-release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years. Good pain control while on a stable dose of an opioid analgesic for osteoarthritis. Exclusion Criteria: Not currently taking and tolerating opioids. Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTDS 5<br>Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear | Drug: Buprenorphine<br>* Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear<br>* Other names: Butrans™;|
| Experimental: BTDS 20<br>Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear | Drug: Buprenorphine<br>* Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear<br>* Other names: Butrans™;|
| Experimental: Oxycodone Immediate-Release (Oxy IR) 40 mg<br>Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). | Drug: oxycodone immediate-release<br>* Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Over the Last 24 Hours Scores at Weeks 4, 8, and 12 of the Double-blind Phase. | The average pain over the last 24 hours score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12). | Weeks 4, 8, and 12 of the double-blind phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Daily Number of Supplemental Analgesic Medication Tablets | The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®. | Double-blind phase (84 days) | 
| The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase | The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete. The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst). | Weeks 4, 8 and 12 of the double-blind phase | 
| The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase | The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. | Weeks 4, 8, and 12 of the Double-blind Phase | 

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