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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 osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal delivery system | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | ||
| dropouts due to lack of efficacy | ||
| MOS health survey |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | United States | ||
| Arizona Research and Education |
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| VAS pain intensity |
| therapeutic response |
| patient preference |
| daily patient diary |
| and number of oxycodone/acetaminophen or placebo tablets taken |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Phoenix Center for Clinical Research | Phoenix | Arizona | 85015 | United States |
| Western Integrated Pain Treatment Centers | Westminster | Colorado | 80030 | United States |
| Gainesville Clinical Research Center | Gainesville | Florida | 32605 | United States |
| Park Place Therapeutic Center | Plantation | Florida | 33324 | United States |
| MediSphere Medical Research Center, L.L.C. | Evansville | Indiana | 47714 | United States |
| Stratton VA Medical Center | Albany | New York | 12208 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75235 | United States |
| Arthritis Diagnostic and Treatment Center | San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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