Status:
COMPLETED
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 and hydrocodone/acetaminophen in...
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 chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
- back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.
Exclusion
- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets 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.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
End Date :
October 1 1999
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00315887
Start Date
April 1 1999
End Date
October 1 1999
Last Update
May 3 2006
Active Locations (22)
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1
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
Arthritis Center of Connecticut
Waterbury, Connecticut, United States, 06708
4
University Clinical Research
DeLand, Florida, United States, 32720