Clinical trial NCT00313846: Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Chronic pain
opioid
transdermal
osteoarthritis
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 529
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

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 diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
* an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

Exclusion Criteria:

* ingest opioid analgesics on a daily basis.
* ingest \>2500 milligrams (mg) acetaminophen on a daily basis.
* require \<20 mg or \>80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
timeFrame: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods
Secondary outcomes:
measure: Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site
timeFrame: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Vista Medical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: ACRC/Arizona Clinical Research
state: Arizona
city: Bakersfield
country: United States
facility: Advance Pain Medicine
state: California
city: Cypress
country: United States
facility: Eastgate Medical Center
state: California
city: Loma Linda
country: United States
facility: University Osteoporosis Ctr
state: California
city: San Diego
country: United States
facility: San Diego Arthritis & Osteoporosis Medical Clinic
state: California
city: San Diego
country: United States
facility: Scripps Clinic Rancho Bernard
state: California
city: San Francisco
country: United States
facility: CNS Clinical Trials, Inc
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Westminster
country: United States
facility: Integrative Treatment Centers/Rocky Mtn Clin Res
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Bridgeport
country: United States
facility: Stamford Therapeutic Consortium
state: Connecticut
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland
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: Port Orange
country: United States
facility: Coastal Medical Research
state: Florida
city: W. Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Weston
country: United States
facility: Gold Coast Research
state: Florida
city: Marietta
country: United States
facility: Non-Surgical Orthopedic & Spine Center
state: Georgia
city: Columbus
country: United States
facility: Columbus Internal Medical Associates
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Ctr.
state: Indiana
city: Murray
country: United States
facility: Primary Care Research
state: Kentucky
city: Cadillac
country: United States
facility: Professional Clinical Research
state: Michigan
city: Traverse City
country: United States
facility: Sound Medical At West Front Primary Care
state: Michigan
city: New York
country: United States
facility: Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
state: New York
city: Winston-Salem
country: United States
facility: All-Trials Clinical Research, LLC
state: North Carolina
city: Altoona
country: United States
facility: Keystone Clinical
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic
state: South Dakota
city: Dallas
country: United States
facility: Private Practice
state: Texas
city: Harker Heights
country: United States
facility: Team Research of Central Texas
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: Seguin
country: United States
facility: ACCU Clinical Research Trials, Inc
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Virgina Beach
country: United States
facility: Advance Pain Management & Rehab
state: Virginia
city: Edmonds
country: United States
facility: Evergreen Clinical Research Associates
state: Washington
city: Tacoma
country: United States
facility: Internal Medicine Northwest
state: Washington
Study officials:
References: