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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Pilot study.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2000

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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