The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back 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 (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 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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Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain

Conditions
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Back Pain

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: unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day. taking >/=3 opioid doses per day with or without acceptable pain control. Exclusion Criteria: receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period. 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 |
| --- | --- | --- |
| Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory |  |  | 
| dropouts due to lack of efficacy |  |  | 
| MOS health survey |  |  | 
| VAS pain intensity |  |  | 
| therapeutic response |  |  | 
| patient preference |  |  | 
| daily patient diary |  |  | 
| and number of oxycodone/acetaminophen or placebo tablets taken |  |  | 

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