Study Stopped
This study was terminated early for administrative reasons.
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase
1 other identifier
interventional
196
1 country
89
Brief Summary
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2004
Shorter than P25 for phase_3
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedResults Posted
Study results publicly available
September 23, 2010
CompletedSeptember 10, 2012
September 1, 2012
1.3 years
June 1, 2010
July 15, 2010
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
52 weeks
Study Arms (1)
BTDS
EXPERIMENTALBuprenorphine transdermal patch
Interventions
Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear.
Eligibility Criteria
You may qualify if:
- Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
You may not qualify if:
- Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
- Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
- Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (89)
Alabama Neurology and Pain Medicine
Alabaster, Alabama, 35007, United States
Research Facility
Birmingham, Alabama, 35215, United States
The Birmingham Pain Center
Birmingham, Alabama, 35244, United States
University of Alabama Hospital
Birmingham, Alabama, 35249, United States
HealthSouth Metro West Hospital
Fairfield, Alabama, 35064, United States
Research Facility
Phoenix, Arizona, 85018, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Research Facility
Phoenix, Arizona, 85029, United States
Research Facility
Tucson, Arizona, 85712, United States
Hot Springs Pain Clinic
Hot Springs, Arkansas, 71913, United States
Research Facility
Buena Park, California, 90620, United States
Research Facility
Chula Vista, California, 91911, United States
Research Facility
Fresno, California, 93720, United States
Research Facility
Los Gatos, California, 95032, United States
Research Facility
Roseville, California, 95661, United States
NTOUCH Research Corporation
San Diego, California, 92103, United States
Research Facility
San Diego, California, 92120, United States
Research Facility
Torrence, California, 90505, United States
Research Facility
Upland, California, 91786, United States
Research Facility
Pueblo, Colorado, 81008, United States
Research Facility
Bridgeport, Connecticut, 06606, United States
Research Facility
Coral Gables, Florida, 33134, United States
Research Facility
Daytona Beach, Florida, 32114, United States
Research Facility
Hialeah, Florida, 33013, United States
Research Facility
Jupiter, Florida, 99458, United States
Research Facility
Largo, Florida, 33770, United States
Research Facility
Miami, Florida, 33155, United States
Research Facility
North Miami Beach, Florida, 33180, United States
Research Facility
Ocala, Florida, 34471, United States
Research Facility
Ormond Beach, Florida, 32174, United States
Research Facility
Palm Harbor, Florida, 34684, United States
Research Facility
Pembroke Pines, Florida, 33024, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Research Facility
Plantation, Florida, 33324, United States
Research Facility
Port Orange, Florida, 32127, United States
Research Facility
Tampa, Florida, 33614, United States
Research Facility
West Palm Beach, Florida, 33409, United States
Research Facility
Marietta, Georgia, 30060, United States
Research Facility
Boise, Idaho, 83702, United States
Idaho Arthritis Osteoporosis
Meridian, Idaho, 83642, United States
Research Facility
Chicago, Illinois, 60610, United States
Research Facility
Springfield, Illinois, 62704, United States
Integrated Clinical Trials
West Des Moines, Iowa, 50265, United States
Louisville Endocrinology PSC
Louisville, Kentucky, 40213, United States
Research Facility
Madisonville, Kentucky, 42431, United States
Research Facility
New Orleans, Louisiana, 70114, United States
Research Facility
New Orleans, Louisiana, 70115, United States
Dolby Providers
New Orleans, Louisiana, 70128, United States
Research Facility
Baltimore, Maryland, 21215, United States
Patuxent Medical Group
Columbia, Maryland, 21045, United States
Research Facility
Hagerstown, Maryland, 21740, United States
Research Facility
Brockton, Massachusetts, 02301, United States
Crystal Lake Health Center
Benzonia, Michigan, 49616, United States
Rheumatology PC
Kalamazoo, Michigan, 49009, United States
Research Facility
Lansing, Michigan, 48917, United States
KC Pain Centers East
Independence, Missouri, 64055, United States
Research Facility
St Louis, Missouri, 63117, United States
HealthCare Research LLC
St Louis, Missouri, 63141, United States
Research Facility
Las Vegas, Nevada, 89106, United States
Research Facility
Las Vegas, Nevada, 89117, United States
Research Facility
New York, New York, 10021, United States
Research Facility
Syracuse, New York, 13210, United States
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
Triangle Orthopaedic Associates
Durham, North Carolina, 27704, United States
Research Facility
Greensboro, North Carolina, 27401, United States
Research Facility
Hickory, North Carolina, 28601, United States
Cornerstone Research Care
High Point, North Carolina, 27262, United States
Research Facility
Cincinnati, Ohio, 45241, United States
Research Facility
Columbus, Ohio, 43235, United States
Research Facility
Oklahoma City, Oklahoma, 73103, United States
Research Facility
Eugene, Oregon, 97404, United States
Research Facility
Altoona, Pennsylvania, 16602, United States
Research Facility
Duncansville, Pennsylvania, 16635, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Research Facility
Mechanicsburg, Pennsylvania, 17055, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Radiant Research
Greer, South Carolina, 29651, United States
Allergy ARTS
Amarillo, Texas, 79124, United States
Research Facility
Conroe, Texas, 77304, United States
Family Practice Associates
Corpus Christi, Texas, 78411, United States
Research Facility
Dallas, Texas, 75218, United States
Research Facility
Dallas, Texas, 75251, United States
Research Facility
Houston, Texas, 77054, United States
KRK Medical Research
Richardson, Texas, 75080, United States
Research Facility
San Antonio, Texas, 78217, United States
Research Facility
San Antonio, Texas, 78238, United States
Research Facility
Spokane, Washington, 99207, United States
Research Facility
Milwaukee, Wisconsin, 53218, United States
Research Facility
New Berlin, Wisconsin, 53151, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early for administrative reasons.
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 2, 2010
Study Start
April 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
September 10, 2012
Results First Posted
September 23, 2010
Record last verified: 2012-09