The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain
1 other identifier
interventional
225
1 country
12
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 chronic low back 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 Apr 1997
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 19, 2006
CompletedMay 14, 2013
May 1, 2013
April 18, 2006
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, 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 (12)
Hawthorne & York, Intl, Ltd
Phoenix, Arizona, 85008, United States
Arizona Research & Education
Phoenix, Arizona, 85012, United States
Gainesville Clinical Research Center
Gainesville, Florida, 32605, United States
Park Place Therapeutic Center
Plantation, Florida, 33324, United States
Atlanta Research Center
Atlanta, Georgia, 30033, United States
Rheumatology Associates, Inc.
Indianapolis, Indiana, 46260, United States
Westside Family Medical Center
Kalamazoo, Michigan, 49009, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
The New York Hospital Cornell Medical Center
New York, New York, 10021, United States
NC Clinical Research, Inc.
Raleigh, North Carolina, 27607, United States
Pain Control Ctr Bowman Gray School of Med
Winston-Salem, North Carolina, 27103, United States
Metroplex Clinical Research Center
Dallas, Texas, 75235, 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
April 1, 1997
Study Completion
January 1, 1998
Last Updated
May 14, 2013
Record last verified: 2013-05