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

NCT00313833 | Completed Phase 3

• 1 other identifier: BUP3002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 18

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.

Conditions

Chronic Pain

Keywords

Chronic pain; elderly; supervised living; opioid; transdermal

Outcome Measures

Primary Outcomes (1)

• Pilot study.

Secondary Outcomes (25)

• 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

Interventions

Buprenorphine transdermal delivery system DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (18)

Birmingham Health Center

Birmingham, Alabama, 35235, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Associated Physicians of Southbury

Southbury, Connecticut, 06488, United States

Location

Life Care Home Health Services

Delray Beach, Florida, 33445, United States

Location

Ward Parkway Health Services

Leawood, Kansas, 66206, United States

Location

Atlantic Medical Group LLC

Baltimore, Maryland, 21208, United States

Location

Bortz Health Care of Warren

Warren, Michigan, 48089, United States

Location

Bio-Test Clinic

Springfield, Missouri, 65807, United States

Location

Glengariff Health Care Center

Glen Cove, New York, 11542, United States

Location

Kings Harbor Multicare Center

The Bronx, New York, 10469, United States

Location

Regency Manor

Columbus, Ohio, 43207, United States

Location

Associated Medical Services Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Town Center Village

Portland, Oregon, 97266, United States

Location

Center for Pain Management

Altoona, Pennsylvania, 16601, United States

Location

LAS/Health and Wellness Center

Zelienople, Pennsylvania, 16063, United States

Location

Geriatric Associates of America Inc PA

Baytown, Texas, 77520, United States

Location

Wisconsin Veterans Home

King, Wisconsin, 54946, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: December 1, 2000
• Study Completion: November 1, 2001
• Last Updated: May 3, 2006

Record last verified: 2006-04

Locations

US (18)