Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
NCT ID: NCT00312572
Last Updated: 2012-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2003-06-30
2004-07-31
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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BTDS10/20
Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their doses adjusted to BTDS 20 (Level 2) on or after day 4.
Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
BTDS 20
Initial doses (Level 1) of BTDS 20.
Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Interventions
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Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
40 Years
85 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Southern Drug Research
Birmingham, Alabama, United States
Redpoint Research
Phoenix, Arizona, United States
Advanced Clinical Therapeutics
Tucson, Arizona, United States
Tucson Orthopedic Institute
Tucson, Arizona, United States
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, United States
Private Practice
Pine Bluff, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Lovelace Scientific Resources
Beverly Hills, California, United States
Southbay Pharma Research
Buena Park, California, United States
Community Medical Providers
Clovis, California, United States
Kaiser Permanente
Escondido, California, United States
Univ. of Southern California
Santa Monica, California, United States
Arthritis Center of CT
Waterbury, Connecticut, United States
Lifespan Research Foundation, Inc.
Miami, Florida, United States
Miami Beach Anesthesiology Associates
Miami Beach, Florida, United States
Neuro Science and Spine Assoc.
Naples, Florida, United States
West Broward Rheumatology Association, Inc.
Tamarac, Florida, United States
Intermountain Orthopaedics
Boise, Idaho, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Bluegrass Orthopaedics
Lexington, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Dolby Providers, Inc.
New Orleans, Louisiana, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Westside Family Medical Center
Kalamazoo, Michigan, United States
PCM Medical Services
Lansing, Michigan, United States
HealthCare Research LLC
St Louis, Missouri, United States
Northeast Pain Research Center
Barrington, New Hampshire, United States
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, United States
Dayton Primary and Urgent Care
Dayton, Ohio, United States
The Medford Medical Clinic
Medford, Oregon, United States
The Arthritis and Osteoporosis Center
Orangeburg, South Carolina, United States
CEDRA Clinical Research,
Austin, Texas, United States
Renaissance Clinical Research & Hypertension Clinic
Dallas, Texas, United States
Spine Care Southwest.
Houston, Texas, United States
KRK Medical Research
Richardson, Texas, United States
Monroe Medical Foundation
Monroe, Wisconsin, United States
Countries
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References
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Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.
Other Identifiers
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BUP3018
Identifier Type: -
Identifier Source: org_study_id