Status:
COMPLETED
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
Lead Sponsor:
Purdue Pharma LP
Collaborating Sponsors:
Napp Pharmaceuticals Limited
Conditions:
Chronic Non-malignant Pain
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 (5, 10 and 20) in comparison to matching placebo transdermal system in subjects...
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
- At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
- Good, very good or excellent pain control on current opioid therapy.
- Willing and able to use a telephone interactive voice response service.
Exclusion
- Currently receiving daily morphine or oxycodone monotherapy.
- Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00312195
Start Date
March 1 2001
End Date
July 1 2001
Last Update
September 10 2012
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Hawthorne and York
Phoenix, Arizona, United States, 85008
2
Arizona Research Center Inc
Phoenix, Arizona, United States, 85023
3
Clinical Research Consultants Inc
Trumbull, Connecticut, United States, 06611
4
Tampa Bay Medical Research Inc
Clearwater, Florida, United States, 33761