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Sponsored by: |
Purdue Pharma LP |
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Information provided by: | Purdue Pharma LP |
ClinicalTrials.gov Identifier: | NCT00314652 |
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 in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.
Condition | Intervention | Phase |
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Osteoarthritis |
Drug: Buprenorphine transdermal delivery system |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee |
Estimated Enrollment: | 260 |
Study Start Date: | June 1999 |
Estimated Study Completion Date: | October 1999 |
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.
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.
United States, Arizona | |
ACRC/Arizona Clinical Research | |
Tucson, Arizona, United States, 85712 | |
Arizona Research Center, LLC | |
Phoenix, Arizona, United States, 85023 | |
Advanced Clinical Therapeutics | |
Tucson, Arizona, United States, 85712 | |
Hawthorne & York, International, Ltd. | |
Phoenix, Arizona, United States, 85008 | |
United States, California | |
Scripps Clinic Rancho Bernardo | |
San Diego, California, United States, 92128 | |
San Diego Arthritis and Osteoporosis Research | |
San Diego, California, United States, 92120 | |
United States, Connecticut | |
Clinical Research Consultants, Inc. | |
Trumbull, Connecticut, United States, 06611 | |
United States, Florida | |
Gold Coast Research, Inc. | |
Weston, Florida, United States, 33331 | |
Gainesville Clinical Research Center | |
Gainesville, Florida, United States, 32605 | |
University Clinical Research, Inc. | |
Pembroke Pines, Florida, United States, 33024 | |
Tampa Bay Medical Research, Inc. | |
Clearwater, Florida, United States, 33761 | |
Physicians Research Associates Jacksonville | |
Jacksonville, Florida, United States, 32216 | |
University Clinical Research | |
Deland, Florida, United States, 32720 | |
United States, Indiana | |
MediSphere Medical Research Center, LLC | |
Evansville, Indiana, United States, 47714 | |
United States, Michigan | |
Westside Family Medical Center | |
Kalamazoo, Michigan, United States, 49009 | |
United States, Missouri | |
Center for Pharmaceutical Research | |
Kansas City, Missouri, United States, 64114 | |
United States, New Jersey | |
NJP Clinical Research | |
Passaic, New Jersey, United States, 07055 | |
United States, North Carolina | |
PW Clinical Research, LLC | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Ohio | |
New Century Research Center, Ltd. | |
Beaverbrook, Ohio, United States, 45431 | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Tennessee | |
Mid-South Clinical Research Institute | |
Memphis, Tennessee, United States, 38120 | |
United States, Utah | |
Advanced Clinical Research | |
Salt Lake City, Utah, United States, 84102 |
Study ID Numbers: | BP99-0203 |
Study First Received: | April 12, 2006 |
Last Updated: | April 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00314652 |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis chronic pain opioid transdermal |
Buprenorphine Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases Osteoarthritis, Hip |
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |