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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313833
• Other study ID #: BUP3002
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2006
• Last updated: April 29, 2006
• Start date: December 2000
• Est. completion date: November 2001

Study information

• Verified date: April 2006
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Buprenorphine transdermal delivery system

Locations

Country	Name	City	State
United States	Center for Pain Management	Altoona	Pennsylvania
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Atlantic Medical Group LLC	Baltimore	Maryland
United States	Geriatric Associates of America Inc PA	Baytown	Texas
United States	Birmingham Health Center	Birmingham	Alabama
United States	Kings Harbor Multicare Center	Bronx	New York
United States	Regency Manor	Columbus	Ohio
United States	Life Care Home Health Services	Delray Beach	Florida
United States	Glengariff Health Care Center	Glen Cove	New York
United States	Wisconsin Veterans Home	King	Wisconsin
United States	Ward Parkway Health Services	Leawood	Kansas
United States	Associated Medical Services Inc	Oklahoma City	Oklahoma
United States	Arizona Research Center	Phoenix	Arizona
United States	Town Center Village	Portland	Oregon
United States	Associated Physicians of Southbury	Southbury	Connecticut
United States	Bio-Test Clinic	Springfield	Missouri
United States	Bortz Health Care of Warren	Warren	Michigan
United States	LAS/Health and Wellness Center	Zelienople	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

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