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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.
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 if applicable, 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 |
|---|---|---|---|---|---|---|
| Hawthorne & York, Intl, Ltd | Phoenix | Arizona | 85008 | United States | ||
| Arizona Research & 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 |
| Gainesville Clinical Research Center | Gainesville | Florida | 32605 | United States |
| Park Place Therapeutic Center | Plantation | Florida | 33324 | United States |
| Atlanta Research Center | Atlanta | Georgia | 30033 | United States |
| Rheumatology Associates, Inc. | Indianapolis | Indiana | 46260 | United States |
| Westside Family Medical Center | Kalamazoo | Michigan | 49009 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| The New York Hospital Cornell Medical Center | New York | New York | 10021 | United States |
| NC Clinical Research, Inc. | Raleigh | North Carolina | 27607 | United States |
| Pain Control Ctr Bowman Gray School of Med | Winston-Salem | North Carolina | 27103 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75235 | United States |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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