Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
NCT ID: NCT00312195
Last Updated: 2012-09-10
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
267 participants
INTERVENTIONAL
2001-03-31
2001-07-31
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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BTDS (5, 10 or 20)
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Placebo to match BTDS
Placebo to match buprenorphine transdermal patch
Placebo to match BTDS
Placebo to match buprenorphine transdermal patch 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 to match BTDS
Placebo to match buprenorphine transdermal patch applied for 7-day wear.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good, very good or excellent pain control on current opioid therapy.
* Willing and able to use a telephone interactive voice response service.
Exclusion Criteria
* Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
18 Years
ALL
No
Sponsors
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Napp Pharmaceuticals Limited
INDUSTRY
Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Hawthorne and York
Phoenix, Arizona, United States
Arizona Research Center Inc
Phoenix, Arizona, United States
Clinical Research Consultants Inc
Trumbull, Connecticut, United States
Tampa Bay Medical Research Inc
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
University Clinical Research Deland
DeLand, Florida, United States
University Clinical Research Inc,
Pembroke Pines, Florida, United States
Gold Coast Research LLC
Plantation, Florida, United States
Gold Coast Research LLC
Tamarac, Florida, United States
Family Medicine Associates
Evansville, Indiana, United States
Pain Management and Rehabilitation
Terre Haute, Indiana, United States
Southeastern Center for Headache and Pain
Crestview Heights, Kentucky, United States
Westside Family Medical Center PC
Kalamazoo, Michigan, United States
The Arthritis Clinic
Charlotte, North Carolina, United States
Cornerstone Research Care
High Point, North Carolina, United States
ALL-TRIALS Clinical Research LLC
Winston-Salem, North Carolina, United States
Private Practice
Chardon, Ohio, United States
Summit Research Solutions
Memphis, Tennessee, United States
Radiant Research
Austin, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Clinical Research Management
New Berlin, Wisconsin, United States
Whiteabbey Health Centre
Newtownabbey, Belfast, United Kingdom
Antrim Coast Fundholding Group
Lame, Co Antrim, United Kingdom
Portglenone Health Centre
Portglenone, CO Antrim, United Kingdom
Garden Street Surgery
Magherafelt, Co Derry, United Kingdom
Springhill Surgery
Bangor, Co Down, United Kingdom
Bennett Road Surgery
Keresley End, Coventry, United Kingdom
Little Common Surgery
Bexhill-on-Sea, E Sussex, United Kingdom
Old Town Surgery
Bexhill-on-Sea, E Sussex, United Kingdom
Roebuck House Surgery
Hastings, E Sussex, United Kingdom
Leslie Surgery
Glenrothes, Fife, United Kingdom
Valleyfield Health Centre
High Valleyfield, Fife, United Kingdom
Townhead Health Centre
Glasgow, Glasgow, United Kingdom
Castlemilk Health Centre
Glasgow, Glasgow, United Kingdom
Ashvale Health Centre
Aldershot, Hants, United Kingdom
The Academy Medical Practice
Coatbridge, Lanarkshire, United Kingdom
Sanbury Health Centre Group Practice
Sunbury-on-Thames, Middx, United Kingdom
Houston Surgery
Houston, Renfrewshire, United Kingdom
The Burns Practice
Doncaster, S Yorkshire, United Kingdom
Grosvenor Medical Centre
Royal Tunbridge Wells, W Sussex, United Kingdom
Gables Medical Section
Coventry, Warwickshire, United Kingdom
The Ridge Medical Practice, Great Horton
Bradford, West Yorkshire, United Kingdom
Countries
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Other Identifiers
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BUP3201
Identifier Type: -
Identifier Source: org_study_id