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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal delivery system
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, elderly, supervised living, opioid, transdermal

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Health Center
  • Arizona Research Center
  • Advanced Clinical Research Institute
  • Associated Physicians of Southbury
  • Life Care Home Health Services
  • Ward Parkway Health Services
  • Atlantic Medical Group LLC
  • Bortz Health Care of Warren
  • Bio-Test Clinic
  • Kings Harbor Multicare Center
  • Glengariff Health Care Center
  • Regency Manor
  • Associated Medical Services Inc
  • Town Center Village
  • Center for Pain Management
  • LAS/Health and Wellness Center
  • Geriatric Associates of America Inc PA
  • Wisconsin Veterans Home

Outcomes

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.

Full Information

First Posted
April 10, 2006
Last Updated
April 29, 2006
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00313833
Brief Title
Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Purdue Pharma LP

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, elderly, supervised living, opioid, transdermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal delivery system
Primary Outcome Measure Information:
Title
Pilot study.
Secondary Outcome Measure Information:
Title
The following outcome variables were assessed:
Title
average pain intensity in the last 24 hours
Title
acceptability of analgesic therapy
Title
number of nighttime awakenings due to pain last night
Title
quality of sleep
Title
bowel status during the last 24 hours
Title
pain management evaluation
Title
symptom evaluation
Title
staff evaluation of functional independence
Title
resident-defined activity impairment scale
Title
treatment satisfaction questionnaire
Title
Health Assessment Questionnaire
Title
Timed "Up & Go" evaluation
Title
trail making test
Title
digit span test
Title
end of study global evaluation of therapeutic response
Title
modified mini-mental state
Title
examination and geriatric depression scale.
Title
The following measures of health resource utilization were assessed:
Title
use of analgesic medications (usual care plus BTDS) by product type
Title
use of analgesic medications (usual care plus BTDS) by medication and dosage form
Title
use of pain-related adjuvant medications by product type
Title
number of phone calls to physicians for pain management
Title
number of physician visits for pain management
Title
and use of medications for the treatment of drug-related adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Birmingham Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Associated Physicians of Southbury
City
Southbury
State/Province
Connecticut
ZIP/Postal Code
06488
Country
United States
Facility Name
Life Care Home Health Services
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Ward Parkway Health Services
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Atlantic Medical Group LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Bortz Health Care of Warren
City
Warren
State/Province
Michigan
ZIP/Postal Code
48089
Country
United States
Facility Name
Bio-Test Clinic
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Kings Harbor Multicare Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Facility Name
Glengariff Health Care Center
City
Glen Cove
State/Province
New York
ZIP/Postal Code
11542
Country
United States
Facility Name
Regency Manor
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Associated Medical Services Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Town Center Village
City
Portland
State/Province
Oregon
ZIP/Postal Code
97266
Country
United States
Facility Name
Center for Pain Management
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
LAS/Health and Wellness Center
City
Zelienople
State/Province
Pennsylvania
ZIP/Postal Code
16063
Country
United States
Facility Name
Geriatric Associates of America Inc PA
City
Baytown
State/Province
Texas
ZIP/Postal Code
77520
Country
United States
Facility Name
Wisconsin Veterans Home
City
King
State/Province
Wisconsin
ZIP/Postal Code
54946
Country
United States

12. IPD Sharing Statement

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

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