Status:
COMPLETED
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen i...
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the rel...
Eligibility Criteria
Inclusion
- clinical evidence of stable, chronic (\>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking \</=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.
Exclusion
- receiving opioids at an average daily dose of \>90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
- scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1998
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00315445
Start Date
December 1 1997
End Date
May 1 1998
Last Update
September 3 2012
Active Locations (12)
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1
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
2
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
3
Phoenix Orthopedic Center, Ltd.
Phoenix, Arizona, United States, 85023
4
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605