Clinical trial NCT00313833: Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
Official title: A Randomized, Double Blind, Pilot Evaluation of the Effectiveness of BTDS Versus Placebo on Health Outcomes Associated With Analgesic Management of Elderly Residents in Supervised Living Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Chronic pain
elderly
supervised living
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Pilot study.
Secondary outcomes:
measure: The following outcome variables were assessed:
measure: average pain intensity in the last 24 hours
measure: acceptability of analgesic therapy
measure: number of nighttime awakenings due to pain last night
measure: quality of sleep
measure: bowel status during the last 24 hours
measure: pain management evaluation
measure: symptom evaluation
measure: staff evaluation of functional independence
measure: resident-defined activity impairment scale
measure: treatment satisfaction questionnaire
measure: Health Assessment Questionnaire
measure: Timed "Up & Go" evaluation
measure: trail making test
measure: digit span test
measure: end of study global evaluation of therapeutic response
measure: modified mini-mental state
measure: examination and geriatric depression scale.
measure: The following measures of health resource utilization were assessed:
measure: use of analgesic medications (usual care plus BTDS) by product type
measure: use of analgesic medications (usual care plus BTDS) by medication and dosage form
measure: use of pain-related adjuvant medications by product type
measure: number of phone calls to physicians for pain management
measure: number of physician visits for pain management
measure: and use of medications for the treatment of drug-related adverse events.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Health Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Southbury
country: United States
facility: Associated Physicians of Southbury
state: Connecticut
city: Delray Beach
country: United States
facility: Life Care Home Health Services
state: Florida
city: Leawood
country: United States
facility: Ward Parkway Health Services
state: Kansas
city: Baltimore
country: United States
facility: Atlantic Medical Group LLC
state: Maryland
city: Warren
country: United States
facility: Bortz Health Care of Warren
state: Michigan
city: Springfield
country: United States
facility: Bio-Test Clinic
state: Missouri
city: Bronx
country: United States
facility: Kings Harbor Multicare Center
state: New York
city: Glen Cove
country: United States
facility: Glengariff Health Care Center
state: New York
city: Columbus
country: United States
facility: Regency Manor
state: Ohio
city: Oklahoma City
country: United States
facility: Associated Medical Services Inc
state: Oklahoma
city: Portland
country: United States
facility: Town Center Village
state: Oregon
city: Altoona
country: United States
facility: Center for Pain Management
state: Pennsylvania
city: Zelienople
country: United States
facility: LAS/Health and Wellness Center
state: Pennsylvania
city: Baytown
country: United States
facility: Geriatric Associates of America Inc PA
state: Texas
city: King
country: United States
facility: Wisconsin Veterans Home
state: Wisconsin
Study officials:
References: