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The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.
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 |
|---|---|---|
| Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating) | ||
| incidence of and time to early discontinuation due to lack of efficacy | ||
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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 Center |
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| investigator's assessment of therapeutic response |
| dose level at the end of titration |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Arthritis Center of Connecticut | Waterbury | Connecticut | 06708 | United States |
| University Clinical Research | DeLand | Florida | 32720 | United States |
| Gainesville Clinical Research Center | Gainesville | Florida | 32605 | United States |
| Miami Research Associates | Miami | Florida | 33173 | United States |
| Sarasota Arthritis Center | Sarasota | Florida | 34239 | United States |
| Coastal Medical Research | South Daytona Beach | Florida | 32119 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Private Practice | Weston | Florida | 33331 | United States |
| Pain Management & Rehabilitation | Terre Haute | Indiana | 47807 | United States |
| Mid-America Rheumatology Consultants | Overland Park | Kansas | 66209 | United States |
| Riverhills Healthcare | Crestview Hills | Kentucky | 41017 | United States |
| Arthritis & Osteoporosis Treatment & Research Center | Jackson | Mississippi | 39216 | United States |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| PrecisionMed, Inc. | Las Vegas | Nevada | 89128 | United States |
| Cornerstone Research Care | High Point | North Carolina | 27262 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Center for Clinical Research | Austin | Texas | 78758 | United States |
| The Arthritis Clinic of Northern Virginia | Arlington | Virginia | 22206 | United States |
| Evergreen Clinical Research | Edmonds | Washington | 98026 | United States |
| Private Practice | Wauwatosa | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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