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

NCT ID: NCT00313833

Last Updated: 2006-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2001-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine transdermal delivery system

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Locations

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Birmingham Health Center

Birmingham, Alabama, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Associated Physicians of Southbury

Southbury, Connecticut, United States

Site Status

Life Care Home Health Services

Delray Beach, Florida, United States

Site Status

Ward Parkway Health Services

Leawood, Kansas, United States

Site Status

Atlantic Medical Group LLC

Baltimore, Maryland, United States

Site Status

Bortz Health Care of Warren

Warren, Michigan, United States

Site Status

Bio-Test Clinic

Springfield, Missouri, United States

Site Status

Glengariff Health Care Center

Glen Cove, New York, United States

Site Status

Kings Harbor Multicare Center

The Bronx, New York, United States

Site Status

Regency Manor

Columbus, Ohio, United States

Site Status

Associated Medical Services Inc

Oklahoma City, Oklahoma, United States

Site Status

Town Center Village

Portland, Oregon, United States

Site Status

Center for Pain Management

Altoona, Pennsylvania, United States

Site Status

LAS/Health and Wellness Center

Zelienople, Pennsylvania, United States

Site Status

Geriatric Associates of America Inc PA

Baytown, Texas, United States

Site Status

Wisconsin Veterans Home

King, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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BUP3002

Identifier Type: -

Identifier Source: org_study_id