Study Stopped
Administrative reasons.
Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
1 other identifier
interventional
107
1 country
48
Brief Summary
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
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 Dec 2003
Shorter than P25 for phase_3
48 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
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 17, 2006
CompletedFirst Posted
Study publicly available on registry
April 18, 2006
CompletedResults Posted
Study results publicly available
September 23, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.2 years
April 17, 2006
July 28, 2010
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) as a Measure of Safety
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
483 days
Study Arms (2)
BTDS
EXPERIMENTALBuprenorphine transdermal patches 10 or 20 mcg/h
Placebo
PLACEBO COMPARATORPlacebo to match buprenorphine transdermal patch 10 or 20
Interventions
Buprenorphine transdermal patch applied for 7-day wear.
Eligibility Criteria
You may qualify if:
- clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
- taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.
You may not qualify if:
- requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
- scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (48)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Clinical Research Consultants
Birmingham, Alabama, 35244, United States
Winston Physician Services, Inc
Haleyville, Alabama, 35565, United States
Private Practice
Muscle Shoals, Alabama, 35661, United States
Clinic for Rheumatic Diseases
Tuscaloosa, Alabama, 35406, United States
Radiant Research
Phoenix, Arizona, 85013, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
ACRC/Arizona Clinical Research
Tuscon, Arizona, 85715, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Southbay Pharma Research
Buena Park, California, 90620, United States
Torrence Clinical Research
Torrance, California, 90505, United States
Comprehensive Neuroscience Inc
Boynton Beach, Florida, 33437, United States
Chiefland Medical Center
Chiefland, Florida, 32626, United States
University Clinical Research Deland
DeLand, Florida, 32720, United States
Florida Medical Research Institute
Gainesville, Florida, 32605, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Coastal Medical Research
Orange City, Florida, 32763, United States
Ormond Medical Arts Pharmaceutical Res Ctr
Ormond Beach, Florida, 32174, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Avancia Research
Pembroke Pines, Florida, 33024, United States
Coastal Medical Research
Port Orange, Florida, 32127, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Gold Coast Research LLC
Weston, Florida, 33321, United States
Georgia Medical Research Institute
Marietta, Georgia, 30060, United States
Internal Medicine Northwest
Gurnee, Illinois, 60031, United States
MediSphere Medical Research Center
Evansville, Indiana, 47714, United States
University of Louisville Medical/Rheumatology
Louisville, Kentucky, 40202, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Future Care Studies
Springfield, Massachusetts, 01107, United States
Bay Area Health Clinic
Bay City, Michigan, 48706, United States
Medex Healthcare Research Inc
St Louis, Missouri, 63108, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
BioMedical Research Associates
Shippensburg, Pennsylvania, 17257, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Low Country Rheumatology
Charleston, South Carolina, 29406, United States
Brown Clinic
Watertown, South Dakota, 57201, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
CSS Research
Memphis, Tennessee, 38119, United States
Prime Care Medical Center
Selmer, Tennessee, 38375, United States
Team Research of Central Texas
Harker Heights, Texas, 76548, United States
Quality Research
San Antonio, Texas, 78209, United States
Advanced Pain Management and Rehab Hilltop Med Center
Virginia Beach, Virginia, 23454, United States
Sentara Medical Group
Virginia Beach, Virginia, 23462, United States
Physicians Clinic of Spokane
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early for administrative reasons. The efficacy data are not presented since the primary objective of this study was changed identifying it as a safety study.
Results Point of Contact
- Title
- Clinical Leader, Executive 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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2006
First Posted
April 18, 2006
Study Start
December 1, 2003
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
September 3, 2012
Results First Posted
September 23, 2010
Record last verified: 2012-08