Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
This study has been completed.
Sponsor:
Purdue Pharma LP
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00314652
First received: April 12, 2006
Last updated: April 29, 2006
Last verified: April 2006
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Purpose
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 |
|---|---|---|
|
Osteoarthritis |
Drug: Buprenorphine transdermal delivery system |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee |
Resource links provided by NLM:
Further study details as provided by Purdue Pharma LP:
Primary Outcome Measures:
- Percentage of patients who were treated successfully for pain management
- a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
Secondary Outcome Measures:
- Average pain intensity and patient satisfaction scores
- Incidence of early discontinuation due to lack of efficacy
- Time to early discontinuation due to lack of efficacy
- Dose level at end of titration
- Investigator’s assessment of therapeutic response
- Diary pain scores
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
- receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
Exclusion Criteria:
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
Other protocol-specific exclusion/inclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314652
Locations
| United States, Arizona | |
| Arizona Research Center, LLC | |
| Phoenix, Arizona, United States, 85023 | |
| Hawthorne & York, International, Ltd. | |
| Phoenix, Arizona, United States, 85008 | |
| ACRC/Arizona Clinical Research | |
| Tucson, Arizona, United States, 85712 | |
| Advanced Clinical Therapeutics | |
| Tucson, Arizona, United States, 85712 | |
| 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 | |
| Tampa Bay Medical Research, Inc. | |
| Clearwater, Florida, United States, 33761 | |
| University Clinical Research | |
| Deland, Florida, United States, 32720 | |
| Gainesville Clinical Research Center | |
| Gainesville, Florida, United States, 32605 | |
| Physicians Research Associates Jacksonville | |
| Jacksonville, Florida, United States, 32216 | |
| University Clinical Research, Inc. | |
| Pembroke Pines, Florida, United States, 33024 | |
| Gold Coast Research, Inc. | |
| Weston, Florida, United States, 33331 | |
| 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 | |
Sponsors and Collaborators
Purdue Pharma LP
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00314652 History of Changes |
| Other Study ID Numbers: | BP99-0203 |
| Study First Received: | April 12, 2006 |
| Last Updated: | April 29, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
Osteoarthritis chronic pain opioid transdermal |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Buprenorphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 21, 2013