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Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
This study has been completed.
First Received: April 10, 2006   Last Updated: April 29, 2006   History of Changes
Sponsored by: Purdue Pharma LP
Information provided by: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00313833
  Purpose

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

Drug Information available for: Buprenorphine Buprenorphine hydrochloride
U.S. FDA Resources
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

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • Pilot study.

Secondary Outcome Measures:
  • 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
  • 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.

Estimated Enrollment: 100
Study Start Date: December 2000
Estimated Study Completion Date: November 2001
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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313833

Locations
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
Sponsors and Collaborators
Purdue Pharma LP
  More Information

No publications provided

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

Keywords provided by Purdue Pharma LP:
Chronic pain
elderly
supervised living
opioid
transdermal

Study placed in the following topic categories:
Buprenorphine
Narcotic Antagonists
Central Nervous System Depressants
Narcotics
Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009