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| Sponsor: | Purdue Pharma LP |
|---|---|
| Information provided by: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT00312572 |
Purpose
The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Buprenorphine transdermal delivery system |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain |
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | July 2004 |
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: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their OA pain.
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Southern Drug Research | |
| Birmingham, Alabama, United States, 35007 | |
| United States, Arizona | |
| Redpoint Research | |
| Phoenix, Arizona, United States, 85029 | |
| Advanced Clinical Therapeutics | |
| Tucson, Arizona, United States, 85712 | |
| Tucson Orthopedic Institute | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Hot Springs Mercy Pain Clinic | |
| Hot Springs, Arkansas, United States, 71913 | |
| Private Practice | |
| Pine Bluff, Arkansas, United States, 71603 | |
| United States, California | |
| Lovelace Scientific Resources | |
| Beverly Hills, California, United States, 90211 | |
| Southbay Pharma Research | |
| Buena Park, California, United States, 90620 | |
| Kaiser Permanente | |
| Escondido, California, United States, 92025 | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Univ. of Southern California | |
| Santa Monica, California, United States, 90404 | |
| Community Medical Providers | |
| Clovis, California, United States, 93611 | |
| United States, Connecticut | |
| Arthritis Center of CT | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Lifespan Research Foundation, Inc. | |
| Miami, Florida, United States, 33186 | |
| Neuro Science and Spine Assoc. | |
| Naples, Florida, United States, 34102 | |
| Miami Beach Anesthesiology Associates | |
| Miami Beach, Florida, United States, 33140 | |
| West Broward Rheumatology Association, Inc. | |
| Tamarac, Florida, United States, 33321 | |
| United States, Idaho | |
| Intermountain Orthopaedics | |
| Boise, Idaho, United States, 83702 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| Bluegrass Orthopaedics | |
| Lexington, Kentucky, United States, 40509 | |
| Commonwealth Biomedical Research, LLC | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Dolby Providers, Inc. | |
| New Orleans, Louisiana, United States, 70128 | |
| United States, Massachusetts | |
| Clinical Pharmacology Study Group | |
| Worcester, Massachusetts, United States, 01610 | |
| United States, Michigan | |
| PCM Medical Services | |
| Lansing, Michigan, United States, 48917 | |
| Westside Family Medical Center | |
| Kalamazoo, Michigan, United States, 49009 | |
| United States, Missouri | |
| HealthCare Research LLC | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Hampshire | |
| Northeast Pain Research Center | |
| Barrington, New Hampshire, United States, 03825 | |
| United States, North Carolina | |
| The Arthritis Clinic and Carolina Bone and Joint | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Ohio | |
| Dayton Primary and Urgent Care | |
| Dayton, Ohio, United States, 45402 | |
| United States, Oregon | |
| The Medford Medical Clinic | |
| Medford, Oregon, United States, 97504 | |
| United States, South Carolina | |
| The Arthritis and Osteoporosis Center | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Texas | |
| Renaissance Clinical Research & Hypertension Clinic | |
| Dallas, Texas, United States, 75235 | |
| Spine Care Southwest. | |
| Houston, Texas, United States, 77074 | |
| KRK Medical Research | |
| Richardson, Texas, United States, 75080 | |
| CEDRA Clinical Research, | |
| Austin, Texas, United States, 78759 | |
| United States, Wisconsin | |
| Monroe Medical Foundation | |
| Monroe, Wisconsin, United States, 53566 | |
More Information
| Study ID Numbers: | BUP3018 |
| Study First Received: | April 7, 2006 |
| Last Updated: | November 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00312572 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Osteoarthritis, opioid, transdermal |
|
Osteoarthritis Joint Diseases Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Rheumatic Diseases Pharmacologic Actions Buprenorphine |
Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Arthritis Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
