Clinical trial NCT00315458: Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: osteoarthritis
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-18
Enrollment: 107
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over 25 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.

Eligibility criteria: Inclusion Criteria:

* clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
* taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

* requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
* scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety
timeFrame: 483 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Haleyville
country: United States
facility: Winston Physician Services, Inc
state: Alabama
city: Muscle Shoals
country: United States
facility: Private Practice
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinic for Rheumatic Diseases
state: Alabama
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tuscon
country: United States
facility: ACRC/Arizona Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Buena Park
country: United States
facility: Southbay Pharma Research
state: California
city: Torrance
country: United States
facility: Torrence Clinical Research
state: California
city: Boynton Beach
country: United States
facility: Comprehensive Neuroscience Inc
state: Florida
city: Chiefland
country: United States
facility: Chiefland Medical Center
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Orange City
country: United States
facility: Coastal Medical Research
state: Florida
city: Ormond Beach,
country: United States
facility: Ormond Medical Arts Pharmaceutical Res Ctr
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pembroke Pines
country: United States
facility: Avancia Research
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Weston
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Marietta
country: United States
facility: Georgia Medical Research Institute
state: Georgia
city: Gurnee
country: United States
facility: Internal Medicine Northwest
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center
state: Indiana
city: Louisville
country: United States
facility: University of Louisville Medical/Rheumatology
state: Kentucky
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: Bay City
country: United States
facility: Bay Area Health Clinic
state: Michigan
city: St Louis
country: United States
facility: Medex Healthcare Research Inc
state: Missouri
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Altoona
country: United States
facility: Keystone Clinical Solutions
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Shippensburg
country: United States
facility: BioMedical Research Associates
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: CSS Research
state: Tennessee
city: Selmer
country: United States
facility: Prime Care Medical Center
state: Tennessee
city: Harker Heights
country: United States
facility: Team Research of Central Texas
state: Texas
city: San Antonio
country: United States
facility: Quality Research
state: Texas
city: Virginia Beach
country: United States
facility: Advanced Pain Management and Rehab Hilltop Med Center
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Medical Group
state: Virginia
city: Spokane
country: United States
facility: Physicians Clinic of Spokane
state: Washington
Study officials:
References: