Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
NCT ID: NCT00320801
Last Updated: 2012-09-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
188 participants
INTERVENTIONAL
2004-01-31
2005-03-31
Brief Summary
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This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
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 5
Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
BTDS 20
Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Interventions
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Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.
Exclusion Criteria
* requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.
40 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah O'Keefe, BSN
Role: STUDY_CHAIR
Purdue Pharma L.P., Stamford, CT
Locations
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Parkway Medical Center
Birmingham, Alabama, United States
Edwards Lake Medical Center
Birmingham, Alabama, United States
Rheumatogogy Associates of N. Alabama,
Huntsville, Alabama, United States
Drug Research and Analysis Corp.
Montgomery, Alabama, United States
Meadowbrook Research
Scottsdale, Arizona, United States
Research Solutions, LLC
Searcy, Arizona, United States
Central Arkansas Research
Hot Springs, Arkansas, United States
Crest Clinical Research, Inc
Anaheim, California, United States
NuLife Clinical Research, Inc.
Anaheim, California, United States
Orange County Clinical Research
Cypress, California, United States
Private Practice
Laguna Hills, California, United States
Andwell Research
Laguna Niguel, California, United States
Valerius Medical Group & Research Center Inc.
Long Beach, California, United States
Anesthesiology and Pain Management
Los Gatos, California, United States
Scripps Clinic Ranchro Bernardo
San Diego, California, United States
Orrin M. Troum & Medical Associates
Santa Monica, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Private Practice
Arvada, Colorado, United States
Mountainview Clinical Research
Denver, Colorado, United States
Private Practice
Aventura, Florida, United States
Medical Research Associates
Clearwater, Florida, United States
LifeSpan Clinical Research
Miami, Florida, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, United States
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, United States
Sarasota Arthritis Center
Sarasota, Florida, United States
University Neurology
Sarasota, Florida, United States
Pinnacle Trials, Inc.
Atlanta, Georgia, United States
Clinical Investigative Services Med College of Georgia
Augusta, Georgia, United States
America's Doctor (SMO)
Gurnee, Illinois, United States
Dolby Providers, Inc.
New Orleans, Louisiana, United States
Professional Clinical Research
Cadillac, Michigan, United States
Private Practice
Oak Park, Michigan, United States
Lake Michigan Clinical Research and Consulting, Inc.
Saint Joseph, Michigan, United States
Research Center of the Ozarks, , MO
Everton, Missouri, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Cherry Hill Orthopedic Surgeons
Cherry Hill, New Jersey, United States
Private Practice
Medford, New Jersey, United States
Univeristy of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States
Crescent Medical Assoc.
Astoria, New York, United States
Private Practice
Plainview, New York, United States
State University of NY at Stonybrook
Stony Brook, New York, United States
Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
Charlotte, North Carolina, United States
Albermarle Family Practice
Elizabeth City, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Odyssey Research Services
Bismarck, North Dakota, United States
Midwest Regional Research
Bellbrook, Ohio, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Lyle, Austin Alexander PA
Tulsa, Oklahoma, United States
Rouge Valley Clinical Research
Medford, Oregon, United States
Southern Oregon Health & Wellness
Medford, Oregon, United States
Keystone Clinical Solutions, Inc.
Altoona, Pennsylvania, United States
Sidney Hillman Medical Center
Philadelphia, Pennsylvania, United States
Arcuri Clinical Research
Philadelphia, Pennsylvania, United States
The Arthritis & Osteoporosis Center
Orangeburg, South Carolina, United States
Alpha Clinical Research
Clarksville, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Integrity Clinical Research, LLC (SMO)
Milan, Tennessee, United States
LifeTree Clinical Reseach
Salt Lake City, Utah, United States
J. Lewis Research Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research Foothill Family Clinic South
Salt Lake City, Utah, United States
Arthritis Clinic of No. Virginia
Arlington, Virginia, United States
MedSource
Richmond, Virginia, United States
Vantage Clinical Research Group
Lacey, Washington, United States
Arthritis Northwest
Seattle, Washington, United States
Clinical Trials Northwest
Yakima, Washington, United States
Countries
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Other Identifiers
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BUP3014 and BUP3014S
Identifier Type: -
Identifier Source: org_study_id
NCT01137422
Identifier Type: -
Identifier Source: nct_alias