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| Sponsored by: |
Purdue Pharma LP |
| Information provided by: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT00315445 |
Purpose
The objective of this study is to assess the safety 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 back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
| Condition | Intervention | Phase |
|
Back Pain |
Drug: Buprenorphine transdermal delivery system |
Phase III |
| MedlinePlus related topics: | Back Pain |
| Drug Information available for: | Oxycodone Oxycodone hydrochloride Buprenorphine Buprenorphine hydrochloride Acetaminophen |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 1997 |
| Estimated Study Completion Date: | May 1998 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
Contacts and Locations| United States, Alabama | |||||
| Rheumatology Associates of North Alabama | |||||
| Huntsville, Alabama, United States, 35801 | |||||
| United States, Arizona | |||||
| Phoenix Orthopedic Center, Ltd. | |||||
| Phoenix, Arizona, United States, 85023 | |||||
| Phoenix Center for Clinical Research | |||||
| Phoenix, Arizona, United States, 85015 | |||||
| United States, Florida | |||||
| SeaView Research | |||||
| Miami, Florida, United States, 33134 | |||||
| Park Place Therapeutic Center | |||||
| Plantation, Florida, United States, 33324 | |||||
| Gainesville Clinical Research Center | |||||
| Gainesville, Florida, United States, 32605 | |||||
| United States, Georgia | |||||
| Atlanta Research Center | |||||
| Decatur, Georgia, United States, 30033 | |||||
| United States, Missouri | |||||
| The Center for Pharmaceutical Research, P.C. | |||||
| Kansas City, Missouri, United States, 64114 | |||||
| United States, New Jersey | |||||
| New Jersey Research Foundation | |||||
| Linwood, New Jersey, United States, 08221 | |||||
| United States, North Carolina | |||||
| North Carolina Clinical Research, Inc. | |||||
| Raleigh, North Carolina, United States, 27607 | |||||
| United States, Texas | |||||
| Research Across America | |||||
| Dallas, Texas, United States, 75234 | |||||
| Metroplex Clinical Research Center | |||||
| Dallas, Texas, United States, 75235 | |||||
| Purdue Pharma LP |
More Information
| Study ID Numbers: | BP96-0604 |
| First Received: | April 17, 2006 |
| Last Updated: | April 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00315445 |
| Health Authority: | United States: Food and Drug Administration |
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