Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase
1 other identifier
interventional
290
1 country
42
Brief Summary
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2003
Shorter than P25 for phase_3
42 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, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedResults Posted
Study results publicly available
September 21, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.3 years
June 2, 2010
July 28, 2010
August 27, 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.
6 months.
Study Arms (1)
BTDS
EXPERIMENTALBuprenorphine transdermal patch
Interventions
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Eligibility Criteria
You may qualify if:
- Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.
You may not qualify if:
- Excluded from the study are subjects who ingest \> 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
- 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 (42)
Vista Medical Research Inc.
Mesa, Arizona, 85206, United States
Arthrocare, Arthritis Care and Research
Phoenix, Arizona, 85012, United States
Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
Phoenix, Arizona, 85015, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Research Facility
Tucson, Arizona, 85712, United States
Advanced Pain Medicine
Bakersfield, California, 93311, United States
Orange County Clinical Research
Cypress, California, 90630, United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120, United States
Research Facility
San Diego, California, 92128, United States
Research Facility
San Francisco, California, 94121, United States
Research Facility
Denver, Colorado, 80209, United States
Research Facility
Westminster, Colorado, 80031, United States
Research Facility
Bridgeport, Connecticut, 06606, United States
Research Facility
Atlantis, Florida, 33462, United States
Allergy, Asthma, Arthritis & Lung
Daytona Beach, Florida, 32114, United States
University Clinical Research Deland
DeLand, Florida, 32720, United States
Research Facility
Jupiter, Florida, 33458, United States
Coastal Medical Research
Orange City, Florida, 32763, United States
Research Facility
Plantation, Florida, 33324, United States
Research Facility
West Palm Beach, Florida, 33409, United States
Research Facility
Marietta, Georgia, 30060, United States
Research Facility
Columbus, Indiana, 47201, United States
Research Facility
Evansville, Indiana, 47712, United States
Primary Care Medical Center
Murray, Kentucky, 42071, United States
Great Lakes Family Care
Cadillac, Michigan, 49601, United States
Research Facility
Traverse City, Michigan, 49684, United States
Beth Israel/Dept. of Pain
New York, New York, 10021, United States
Research Facility
Winston-Salem, North Carolina, 27103, United States
Research Facility
Cresson, Pennsylvania, 16630, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University Orthopedics & Sport Medicine Center
State College, Pennsylvania, 16801, United States
Research Facility
West Reading, Pennsylvania, 19611, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Central Plains Clin-Brown Site
Watertown, South Dakota, 57201, United States
Research Facility
Dallas, Texas, 75251, United States
Research Facility
Harker Heights, Texas, 76548, United States
Research Facility
San Antonio, Texas, 78217, United States
Research Facility
Seguin, Texas, 78155, United States
Granger Medical Clinic
West Valley City, Utah, 84120, United States
Hilltop Medical Center
Virginia Beach, Virginia, 23454, United States
Research Facility
Bellevue, Washington, 98026, United States
Internal Medicine Northwest
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader, Medical Director
- Organization
- Purdue Pharma LP
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 10, 2010
Study Start
April 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
September 3, 2012
Results First Posted
September 21, 2010
Record last verified: 2012-08