Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Purdue Pharma LP |
---|---|
Information provided by: | Purdue Pharma LP |
ClinicalTrials.gov Identifier: | NCT00313833 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Pain |
Drug: Buprenorphine transdermal delivery system |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 100 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | November 2001 |
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
United States, Alabama | |
Birmingham Health Center | |
Birmingham, Alabama, United States, 35235 | |
United States, Arizona | |
Arizona Research Center | |
Phoenix, Arizona, United States, 85023 | |
United States, California | |
Advanced Clinical Research Institute | |
Anaheim, California, United States, 92801 | |
United States, Connecticut | |
Associated Physicians of Southbury | |
Southbury, Connecticut, United States, 06488 | |
United States, Florida | |
Life Care Home Health Services | |
Delray Beach, Florida, United States, 33445 | |
United States, Kansas | |
Ward Parkway Health Services | |
Leawood, Kansas, United States, 66206 | |
United States, Maryland | |
Atlantic Medical Group LLC | |
Baltimore, Maryland, United States, 21208 | |
United States, Michigan | |
Bortz Health Care of Warren | |
Warren, Michigan, United States, 48089 | |
United States, Missouri | |
Bio-Test Clinic | |
Springfield, Missouri, United States, 65807 | |
United States, New York | |
Kings Harbor Multicare Center | |
Bronx, New York, United States, 10469 | |
Glengariff Health Care Center | |
Glen Cove, New York, United States, 11542 | |
United States, Ohio | |
Regency Manor | |
Columbus, Ohio, United States, 43207 | |
United States, Oklahoma | |
Associated Medical Services Inc | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Oregon | |
Town Center Village | |
Portland, Oregon, United States, 97266 | |
United States, Pennsylvania | |
Center for Pain Management | |
Altoona, Pennsylvania, United States, 16601 | |
LAS/Health and Wellness Center | |
Zelienople, Pennsylvania, United States, 16063 | |
United States, Texas | |
Geriatric Associates of America Inc PA | |
Baytown, Texas, United States, 77520 | |
United States, Wisconsin | |
Wisconsin Veterans Home | |
King, Wisconsin, United States, 54946 |
Study ID Numbers: | BUP3002 |
Study First Received: | April 10, 2006 |
Last Updated: | April 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00313833 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic pain elderly supervised living opioid transdermal |
Buprenorphine Narcotic Antagonists Central Nervous System Depressants Narcotics |
Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Buprenorphine Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants |
Narcotics Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |