Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee
1 other identifier
interventional
260
1 country
22
Brief Summary
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.
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 Jun 1999
Shorter than P25 for phase_3
22 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
June 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
April 12, 2006
CompletedFirst Posted
Study publicly available on registry
April 14, 2006
CompletedMay 3, 2006
April 1, 2006
April 12, 2006
April 29, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of patients who were treated successfully for pain management
a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
Secondary Outcomes (6)
Average pain intensity and patient satisfaction scores
Incidence of early discontinuation due to lack of efficacy
Time to early discontinuation due to lack of efficacy
Dose level at end of titration
Investigator's assessment of therapeutic response
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
- receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.
You may not qualify if:
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (22)
Hawthorne & York, International, Ltd.
Phoenix, Arizona, 85008, United States
Arizona Research Center, LLC
Phoenix, Arizona, 85023, United States
ACRC/Arizona Clinical Research
Tucson, Arizona, 85712, United States
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
San Diego Arthritis and Osteoporosis Research
San Diego, California, 92120, United States
Scripps Clinic Rancho Bernardo
San Diego, California, 92128, United States
Clinical Research Consultants, Inc.
Trumbull, Connecticut, 06611, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761, United States
University Clinical Research
DeLand, Florida, 32720, United States
Gainesville Clinical Research Center
Gainesville, Florida, 32605, United States
Physicians Research Associates Jacksonville
Jacksonville, Florida, 32216, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Gold Coast Research, Inc.
Weston, Florida, 33331, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Westside Family Medical Center
Kalamazoo, Michigan, 49009, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
NJP Clinical Research
Passaic, New Jersey, 07055, United States
PW Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
New Century Research Center, Ltd.
Beaverbrook, Ohio, 45431, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Mid-South Clinical Research Institute
Memphis, Tennessee, 38120, United States
Advanced Clinical Research
Salt Lake City, Utah, 84102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 12, 2006
First Posted
April 14, 2006
Study Start
June 1, 1999
Study Completion
October 1, 1999
Last Updated
May 3, 2006
Record last verified: 2006-04