Status:
COMPLETED
Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Chronic Pain
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environ...
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
- residing in a nursing home, assisted living environment, or any type of supervised living situation in which the principal investigator maintained primary responsibility for the analgesic management of the resident.
- chronic pain of musculoskeletal origin who had been managed with short-acting opioids.
Exclusion
- taking \>90 mg oral morphine sulfate per day (during any single day) or \>50 mcg/hr of transdermal fentanyl or its equivalent.
- activity restricted totally to bed rest.
- have cancer-related pain.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2001
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00313833
Start Date
December 1 2000
End Date
November 1 2001
Last Update
May 3 2006
Active Locations (18)
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1
Birmingham Health Center
Birmingham, Alabama, United States, 35235
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
4
Associated Physicians of Southbury
Southbury, Connecticut, United States, 06488