Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
- Conditions
- Chronic Pain
- Registration Number
- NCT00313833
- Lead Sponsor
- Purdue Pharma LP
- 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 environments. The treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) will be provided to all subjects in addition to study drug.
- 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 relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pilot study.
- Secondary Outcome Measures
Name Time Method end of study global evaluation of therapeutic response The following outcome variables were assessed: average pain intensity in the last 24 hours acceptability of analgesic therapy number of nighttime awakenings due to pain last night quality of sleep bowel status during the last 24 hours pain management evaluation symptom evaluation staff evaluation of functional independence resident-defined activity impairment scale treatment satisfaction questionnaire Health Assessment Questionnaire Timed "Up & Go" evaluation trail making test digit span test modified mini-mental state examination and geriatric depression scale. The following measures of health resource utilization were assessed: use of analgesic medications (usual care plus BTDS) by product type use of analgesic medications (usual care plus BTDS) by medication and dosage form use of pain-related adjuvant medications by product type number of phone calls to physicians for pain management number of physician visits for pain management and use of medications for the treatment of drug-related adverse events.
Trial Locations
- Locations (18)
Bortz Health Care of Warren
🇺🇸Warren, Michigan, United States
Birmingham Health Center
🇺🇸Birmingham, Alabama, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Kings Harbor Multicare Center
🇺🇸Bronx, New York, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Ward Parkway Health Services
🇺🇸Leawood, Kansas, United States
Wisconsin Veterans Home
🇺🇸King, Wisconsin, United States
Glengariff Health Care Center
🇺🇸Glen Cove, New York, United States
Life Care Home Health Services
🇺🇸Delray Beach, Florida, United States
Bio-Test Clinic
🇺🇸Springfield, Missouri, United States
Center for Pain Management
🇺🇸Altoona, Pennsylvania, United States
Geriatric Associates of America Inc PA
🇺🇸Baytown, Texas, United States
Regency Manor
🇺🇸Columbus, Ohio, United States
LAS/Health and Wellness Center
🇺🇸Zelienople, Pennsylvania, United States
Atlantic Medical Group LLC
🇺🇸Baltimore, Maryland, United States
Associated Physicians of Southbury
🇺🇸Southbury, Connecticut, United States
Associated Medical Services Inc
🇺🇸Oklahoma City, Oklahoma, United States
Town Center Village
🇺🇸Portland, Oregon, United States