Status:
COMPLETED
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
Lead Sponsor:
Purdue Pharma LP
Conditions:
Chronic Nonmalignant Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain ...
Detailed Description
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate a...
Eligibility Criteria
Inclusion
- Include:
- Subjects of either sex aged 18 years or older.
- Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.
Exclusion
- Include:
- Subjects currently receiving daily morphine or oxycodone (mono-therapy).
- Subjects who are discontinued from BUP3201 due to adverse events.
- Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.
- Refer to core study for additional inclusion/exclusion information.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2002
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT01151098
Start Date
April 1 2001
End Date
February 1 2002
Last Update
September 10 2012
Active Locations (19)
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1
Arizona Research Center Inc.
Phoenix, Arizona, United States, 85023
2
Clinical Research Consultants Inc
Trumbull, Connecticut, United States, 06611
3
Tampa Bay Medical Research Inc
Clearwater, Florida, United States, 33761
4
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134