Status:
COMPLETED
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain afte...
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
- underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively.
- in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery.
Exclusion
- receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents.
- have significant concurrent pulmonary conditions.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
October 1 1996
Trial Type :
INTERVENTIONAL
End Date :
November 1 1997
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00315835
Start Date
October 1 1996
End Date
November 1 1997
Last Update
April 19 2006
Active Locations (1)
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1
Park Place Therapeutic Center
Plantation, Florida, United States, 33324