Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.

Completed · Phase 3

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT00313833

Run by

Purdue Pharma LP

People needed

100

Starts

2000-12-01

Expected to finish

2001-11-01

Last updated by the study team

2006-05-03

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Birmingham Health Center — Birmingham, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• 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
• Kings Harbor Multicare Center — The Bronx, New York, United States
• Regency Manor — Columbus, Ohio, United States
• Associated Medical Services Inc — Oklahoma City, Oklahoma, United States
• Town Center Village — Portland, Oregon, United States
• Center for Pain Management — Altoona, Pennsylvania, United States
• LAS/Health and Wellness Center — Zelienople, Pennsylvania, United States
• Geriatric Associates of America Inc PA — Baytown, Texas, United States
• Wisconsin Veterans Home — King, Wisconsin, United States

Full record on ClinicalTrials.gov

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