The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
1 other identifier
interventional
225
1 country
10
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
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 Nov 1996
Typical duration for phase_3
10 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
November 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 19, 2006
CompletedMay 3, 2006
April 1, 2006
April 18, 2006
April 29, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
Secondary Outcomes (8)
Brief Pain Inventory
dropouts due to lack of efficacy
MOS health survey
VAS pain intensity
therapeutic response
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day.
- taking \>/=3 opioid doses per day with or without acceptable pain control.
You may not qualify if:
- receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
- scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (10)
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
Arizona Research and Education
Phoenix, Arizona, 85012, United States
Phoenix Center for Clinical Research
Phoenix, Arizona, 85015, United States
Western Integrated Pain Treatment Centers
Westminster, Colorado, 80030, United States
Gainesville Clinical Research Center
Gainesville, Florida, 32605, United States
Park Place Therapeutic Center
Plantation, Florida, 33324, United States
MediSphere Medical Research Center, L.L.C.
Evansville, Indiana, 47714, United States
Stratton VA Medical Center
Albany, New York, 12208, United States
Metroplex Clinical Research Center
Dallas, Texas, 75235, United States
Arthritis Diagnostic and Treatment Center
San Antonio, Texas, 78240, 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 18, 2006
First Posted
April 19, 2006
Study Start
November 1, 1996
Study Completion
December 1, 1999
Last Updated
May 3, 2006
Record last verified: 2006-04