Status:
TERMINATED
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
Lead Sponsor:
Purdue Pharma LP
Conditions:
Back Pain Lower Back Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and ox...
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of mo...
Eligibility Criteria
Inclusion
- low back pain for 3 months or longer, confirmed by radiographic evidence.
- receiving a stable dose of an opioid analgesic for low back pain.
Exclusion
- taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00313014
Start Date
February 1 2004
End Date
September 1 2005
Last Update
September 3 2012
Active Locations (85)
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1
Birmingham Pain Center
Birmingham, Alabama, United States, 35244
2
Arthritis Clinical Intervention Program
Birmingham, Alabama, United States, 35249
3
Winston Physician Services, LLC
Haleyville, Alabama, United States, 35565
4
Arizona Research Center, Inc.
Phoenix, Arizona, United States, 85023