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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Birmingham Health Center
Birmingham, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Pilot study.
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
end of study global evaluation of therapeutic response
modified mini-mental state
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Advanced Clinical Research Institute
Anaheim, California, United States
Associated Physicians of Southbury
Southbury, Connecticut, United States
Life Care Home Health Services
Delray Beach, Florida, United States
Ward Parkway Health Services
Leawood, Kansas, United States
Atlantic Medical Group LLC
Baltimore, Maryland, United States
Bortz Health Care of Warren
Warren, Michigan, United States
Bio-Test Clinic
Springfield, Missouri, United States
Glengariff Health Care Center
Glen Cove, New York, United States
...and 8 more locations
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.