Study Stopped
This study was terminated early due to administrative reasons.
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.
1 other identifier
interventional
188
1 country
66
Brief Summary
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. 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.
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 Jan 2004
Shorter than P25 for phase_3
66 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
January 1, 2004
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 28, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedResults Posted
Study results publicly available
September 20, 2010
CompletedSeptember 3, 2012
August 1, 2012
1.2 years
April 28, 2006
July 28, 2010
August 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Study Arms (2)
BTDS 5
ACTIVE COMPARATORBuprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
BTDS 20
EXPERIMENTALBuprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
Interventions
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Eligibility Criteria
You may qualify if:
- osteoarthritis of the hip, knee, or spine for 1 year or longer.
- taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.
You may not qualify if:
- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (66)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Edwards Lake Medical Center
Birmingham, Alabama, 35235, United States
Rheumatogogy Associates of N. Alabama,
Huntsville, Alabama, 35801, United States
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106, United States
Meadowbrook Research
Scottsdale, Arizona, 85251, United States
Research Solutions, LLC
Searcy, Arizona, 72143, United States
Central Arkansas Research
Hot Springs, Arkansas, 71913, United States
Crest Clinical Research, Inc
Anaheim, California, 92804, United States
NuLife Clinical Research, Inc.
Anaheim, California, 92805, United States
Orange County Clinical Research
Cypress, California, 90630, United States
Private Practice
Laguna Hills, California, 90404, United States
Andwell Research
Laguna Niguel, California, 92677, United States
Valerius Medical Group & Research Center Inc.
Long Beach, California, 90802, United States
Anesthesiology and Pain Management
Los Gatos, California, 95032, United States
Scripps Clinic Ranchro Bernardo
San Diego, California, 92128, United States
Orrin M. Troum & Medical Associates
Santa Monica, California, 90404, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Private Practice
Arvada, Colorado, 80005, United States
Mountainview Clinical Research
Denver, Colorado, 80209, United States
Private Practice
Aventura, Florida, 33180, United States
Medical Research Associates
Clearwater, Florida, 33761, United States
LifeSpan Clinical Research
Miami, Florida, 33186, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, 34769, United States
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, 34769, United States
Sarasota Arthritis Center
Sarasota, Florida, 34239, United States
University Neurology
Sarasota, Florida, 34243, United States
Pinnacle Trials, Inc.
Atlanta, Georgia, 30329, United States
Clinical Investigative Services Med College of Georgia
Augusta, Georgia, 30912, United States
America's Doctor (SMO)
Gurnee, Illinois, 60031, United States
Dolby Providers, Inc.
New Orleans, Louisiana, 70128, United States
Professional Clinical Research
Cadillac, Michigan, 49601, United States
Private Practice
Oak Park, Michigan, 48237, United States
Lake Michigan Clinical Research and Consulting, Inc.
Saint Joseph, Michigan, 49085, United States
Research Center of the Ozarks, , MO
Everton, Missouri, 65646, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Cherry Hill Orthopedic Surgeons
Cherry Hill, New Jersey, 08002, United States
Private Practice
Medford, New Jersey, 08055, United States
Univeristy of Medicine and Dentistry of New Jersey
Stratford, New Jersey, 08084, United States
Crescent Medical Assoc.
Astoria, New York, 11102, United States
Private Practice
Plainview, New York, 11803, United States
State University of NY at Stonybrook
Stony Brook, New York, 11794, United States
Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
Charlotte, North Carolina, 28207, United States
Albermarle Family Practice
Elizabeth City, North Carolina, 27909, United States
New Hanover Medical Research
Wilmington, North Carolina, 28412, United States
Odyssey Research Services
Bismarck, North Dakota, 58501, United States
Midwest Regional Research
Bellbrook, Ohio, 45305, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Lyle, Austin Alexander PA
Tulsa, Oklahoma, 74104, United States
Rouge Valley Clinical Research
Medford, Oregon, 97504, United States
Southern Oregon Health & Wellness
Medford, Oregon, 97504, United States
Keystone Clinical Solutions, Inc.
Altoona, Pennsylvania, 16602, United States
Sidney Hillman Medical Center
Philadelphia, Pennsylvania, 19103, United States
Arcuri Clinical Research
Philadelphia, Pennsylvania, 19142, United States
The Arthritis & Osteoporosis Center
Orangeburg, South Carolina, 29118, United States
Alpha Clinical Research
Clarksville, Tennessee, 37043, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Integrity Clinical Research, LLC (SMO)
Milan, Tennessee, 38358, United States
LifeTree Clinical Reseach
Salt Lake City, Utah, 84106, United States
J. Lewis Research Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Arthritis Clinic of No. Virginia
Arlington, Virginia, 22205, United States
MedSource
Richmond, Virginia, 23229, United States
Vantage Clinical Research Group
Lacey, Washington, 98516, United States
Arthritis Northwest
Seattle, Washington, 98166, United States
Clinical Trials Northwest
Yakima, Washington, 98902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study terminated due to administrative reasons. The primary objective was changed to a safety study prior to unblinding.
Results Point of Contact
- Title
- Clinical Leader, Executive Medical Director
- Organization
- Purdue Pharma L.P.
Study Officials
- STUDY CHAIR
Sarah O'Keefe, BSN
Purdue Pharma L.P., Stamford, CT
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 28, 2006
First Posted
May 3, 2006
Study Start
January 1, 2004
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
September 3, 2012
Results First Posted
September 20, 2010
Record last verified: 2012-08