Clinical trial NCT00320801: Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Official title: A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Chronic pain
osteoarthritis
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 188
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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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:

* osteoarthritis of the hip, knee, or spine for 1 year or longer.
* taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

Exclusion Criteria:

* taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
* requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
timeFrame: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Edwards Lake Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Rheumatogogy Associates of N. Alabama,
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corp.
state: Alabama
city: Scottsdale
country: United States
facility: Meadowbrook Research
state: Arizona
city: Searcy
country: United States
facility: Research Solutions, LLC
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Anaheim
country: United States
facility: Crest Clinical Research, Inc
state: California
city: Anaheim
country: United States
facility: NuLife Clinical Research, Inc.
state: California
city: Cypress
country: United States
facility: Orange County Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Private Practice
state: California
city: Laguna Niguel
country: United States
facility: Andwell Research
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group & Research Center Inc.
state: California
city: Los Gatos
country: United States
facility: Anesthesiology and Pain Management
state: California
city: San Diego
country: United States
facility: Scripps Clinic Ranchro Bernardo
state: California
city: Santa Monica
country: United States
facility: Orrin M. Troum & Medical Associates
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Arvada
country: United States
facility: Private Practice
state: Colorado
city: Denver
country: United States
facility: Mountainview Clinical Research
state: Colorado
city: Aventura
country: United States
facility: Private Practice
state: Florida
city: Clearwater
country: United States
facility: Medical Research Associates
state: Florida
city: Miami
country: United States
facility: LifeSpan Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: Sarasota
country: United States
facility: University Neurology
state: Florida
city: St. Cloud
country: United States
facility: Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
state: Florida
city: St. Cloud
country: United States
facility: Wilker/Powers Center for Clinical Studies
state: Florida
city: Atlanta
country: United States
facility: Pinnacle Trials, Inc.
state: Georgia
city: Augusta
country: United States
facility: Clinical Investigative Services Med College of Georgia
state: Georgia
city: Gurnee
country: United States
facility: America's Doctor (SMO)
state: Illinois
city: New Orleans
country: United States
facility: Dolby Providers, Inc.
state: Louisiana
city: Cadillac
country: United States
facility: Professional Clinical Research
state: Michigan
city: Oak Park
country: United States
facility: Private Practice
state: Michigan
city: St. Joseph
country: United States
facility: Lake Michigan Clinical Research and Consulting, Inc.
state: Michigan
city: Everton
country: United States
facility: Research Center of the Ozarks, , MO
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Cherry Hill
country: United States
facility: Cherry Hill Orthopedic Surgeons
state: New Jersey
city: Medford
country: United States
facility: Private Practice
state: New Jersey
city: Stratford
country: United States
facility: Univeristy of Medicine and Dentistry of New Jersey
state: New Jersey
city: Astoria
country: United States
facility: Crescent Medical Assoc.
state: New York
city: Plainview
country: United States
facility: Private Practice
state: New York
city: Stonybrook
country: United States
facility: State University of NY at Stonybrook
state: New York
city: Charlotte
country: United States
facility: Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
state: North Carolina
city: Elizabeth City
country: United States
facility: Albermarle Family Practice
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Bismark
country: United States
facility: Odyssey Research Services
state: North Dakota
city: Bellbrook
country: United States
facility: Midwest Regional Research
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Lyle, Austin Alexander PA
state: Oklahoma
city: Medford
country: United States
facility: Rouge Valley Clinical Research
state: Oregon
city: Medford
country: United States
facility: Southern Oregon Health & Wellness
state: Oregon
city: Altoona
country: United States
facility: Keystone Clinical Solutions, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sidney Hillman Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arcuri Clinical Research
state: Pennsylvania
city: Orangeburg
country: United States
facility: The Arthritis & Osteoporosis Center
state: South Carolina
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Milan
country: United States
facility: Integrity Clinical Research, LLC (SMO)
state: Tennessee
city: Salt Lake City
country: United States
facility: LifeTree Clinical Reseach
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Foothill Family Clinic South
state: Utah
city: Arlington
country: United States
facility: Arthritis Clinic of No. Virginia
state: Virginia
city: Richmond
country: United States
facility: MedSource
state: Virginia
city: Lacey
country: United States
facility: Vantage Clinical Research Group
state: Washington
city: Seattle
country: United States
facility: Arthritis Northwest
state: Washington
city: Yakima
country: United States
facility: Clinical Trials Northwest
state: Washington
Study officials:
affiliation: Purdue Pharma L.P., Stamford, CT
name: Sarah O'Keefe, BSN
role: STUDY_CHAIR
References: