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

April 29, 2006 updated by: Purdue Pharma LP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Birmingham Health Center
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
    • Connecticut
      • Southbury, Connecticut, United States, 06488
        • Associated Physicians of Southbury
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Life Care Home Health Services
    • Kansas
      • Leawood, Kansas, United States, 66206
        • Ward Parkway Health Services
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Atlantic Medical Group LLC
    • Michigan
      • Warren, Michigan, United States, 48089
        • Bortz Health Care of Warren
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Bio-Test Clinic
    • New York
      • Bronx, New York, United States, 10469
        • Kings Harbor Multicare Center
      • Glen Cove, New York, United States, 11542
        • Glengariff Health Care Center
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Regency Manor
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Associated Medical Services Inc
    • Oregon
      • Portland, Oregon, United States, 97266
        • Town Center Village
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Center for Pain Management
      • Zelienople, Pennsylvania, United States, 16063
        • LAS/Health and Wellness Center
    • Texas
      • Baytown, Texas, United States, 77520
        • Geriatric Associates of America Inc PA
    • Wisconsin
      • King, Wisconsin, United States, 54946
        • Wisconsin Veterans Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pilot study.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

November 1, 2001

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (ESTIMATE)

April 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2006

Last Update Submitted That Met QC Criteria

April 29, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUP3002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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