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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00313833
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : May 3, 2006
Sponsor:
Information provided by:
Purdue Pharma LP

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Buprenorphine transdermal delivery system Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2000
Study Completion Date : November 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




Primary Outcome Measures :
  1. Pilot study.

Secondary Outcome Measures :
  1. The following outcome variables were assessed:
  2. average pain intensity in the last 24 hours
  3. acceptability of analgesic therapy
  4. number of nighttime awakenings due to pain last night
  5. quality of sleep
  6. bowel status during the last 24 hours
  7. pain management evaluation
  8. symptom evaluation
  9. staff evaluation of functional independence
  10. resident-defined activity impairment scale
  11. treatment satisfaction questionnaire
  12. Health Assessment Questionnaire
  13. Timed "Up & Go" evaluation
  14. trail making test
  15. digit span test
  16. end of study global evaluation of therapeutic response
  17. modified mini-mental state
  18. examination and geriatric depression scale.
  19. The following measures of health resource utilization were assessed:
  20. use of analgesic medications (usual care plus BTDS) by product type
  21. use of analgesic medications (usual care plus BTDS) by medication and dosage form
  22. use of pain-related adjuvant medications by product type
  23. number of phone calls to physicians for pain management
  24. number of physician visits for pain management
  25. and use of medications for the treatment of drug-related adverse events.


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313833


Locations
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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

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ClinicalTrials.gov Identifier: NCT00313833     History of Changes
Other Study ID Numbers: BUP3002
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: April 2006

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

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists