Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
NCT ID: NCT00313846
Last Updated: 2012-09-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
529 participants
INTERVENTIONAL
2003-04-30
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BTDS
Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Placebo
Placebo to match BTDS 5, 10 or 20 mcg/h
Placebo
Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
Interventions
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Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Placebo
Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
Exclusion Criteria
* ingest \>2500 milligrams (mg) acetaminophen on a daily basis.
* require \<20 mg or \>80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
40 Years
75 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Vista Medical Research
Mesa, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Radiant Research
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
ACRC/Arizona Clinical Research
Tucson, Arizona, United States
Advance Pain Medicine
Bakersfield, California, United States
Eastgate Medical Center
Cypress, California, United States
University Osteoporosis Ctr
Loma Linda, California, United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, United States
Scripps Clinic Rancho Bernard
San Diego, California, United States
CNS Clinical Trials, Inc
San Francisco, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Integrative Treatment Centers/Rocky Mtn Clin Res
Westminster, Colorado, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Stamford Therapeutic Consortium
Bridgeport, Connecticut, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States
University Clinical Research Deland
DeLand, Florida, United States
Drug Study Institute
Jupiter, Florida, United States
Coastal Medical Research
Orange City, Florida, United States
Coastal Medical Research
Port Orange, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Gold Coast Research
Weston, Florida, United States
Non-Surgical Orthopedic & Spine Center
Marietta, Georgia, United States
Columbus Internal Medical Associates
Columbus, Indiana, United States
MediSphere Medical Research Ctr.
Evansville, Indiana, United States
Primary Care Research
Murray, Kentucky, United States
Professional Clinical Research
Cadillac, Michigan, United States
Sound Medical At West Front Primary Care
Traverse City, Michigan, United States
Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
New York, New York, United States
All-Trials Clinical Research, LLC
Winston-Salem, North Carolina, United States
Keystone Clinical
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, United States
Low Country Rheumatology
Charleston, South Carolina, United States
Brown Clinic
Watertown, South Dakota, United States
Private Practice
Dallas, Texas, United States
Team Research of Central Texas
Harker Heights, Texas, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, United States
ACCU Clinical Research Trials, Inc
Seguin, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Advance Pain Management & Rehab
Virgina Beach, Virginia, United States
Evergreen Clinical Research Associates
Edmonds, Washington, United States
Internal Medicine Northwest
Tacoma, Washington, United States
Countries
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Other Identifiers
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BUP3012
Identifier Type: -
Identifier Source: org_study_id