Clinical trial NCT00531427: Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Official title: Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Osteoarthritis of the Knee
Keywords: Chronic pain,
OA of the knee,
opioid,
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 567
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 objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Eligibility criteria: Inclusion Criteria:

* subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
* clinical diagnosis of OA of the knee 1 year or longer,
* subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \< 5 mg oxycodone (or equivalent) per day,
* subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Exclusion Criteria:

* subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
* subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
* subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
timeFrame: 24 hours (week 12)
Secondary outcomes:
measure: Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
timeFrame: 10 weeks
measure: Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
timeFrame: Weeks 4, 8, and 12 of the double-bind phase
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Phoenix Southeast
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Anaheim
country: United States
facility: Research Facility
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Downey
country: United States
facility: Research Facility
state: California
city: Foothill Ranch
country: United States
facility: Research Facility
state: California
city: Laguna Hills
country: United States
facility: Research Facility
state: California
city: Sacramento
country: United States
facility: Research Facility
state: California
city: Littleton
country: United States
facility: Research Facility
state: Colorado
city: Stamford
country: United States
facility: Research Facility
state: Connecticut
city: Bradenton
country: United States
facility: Coastal Pain Management
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Clearwater
country: United States
facility: Research Facility
state: Florida
city: Jupiter
country: United States
facility: Research Facility
state: Florida
city: Largo
country: United States
facility: Research Facility
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: Research Facility
state: Florida
city: Orlando
country: United States
facility: Research Facility
state: Florida
city: Plantation
country: United States
facility: Research Facility
state: Florida
city: Royal Palm
country: United States
facility: Research Facility
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Flor
state: Florida
city: Tampa
country: United States
facility: Research Facility
state: Florida
city: Venice
country: United States
facility: Research Facility
state: Florida
city: West Palm Beach
country: United States
facility: Research Facility
state: Florida
city: Atlanta
country: United States
facility: Research Facility
state: Georgia
city: Augusta
country: United States
facility: Research Facility
state: Georgia
city: Bogart
country: United States
facility: AMR Research Associates
state: Georgia
city: Dawsonville
country: United States
facility: Research Facility
state: Georgia
city: Decatur
country: United States
facility: Research Facility
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Honolulu
country: United States
facility: Research Facility
state: Hawaii
city: Indianapolis
country: United States
facility: Rehabilitation Association of IN
state: Indiana
city: Overland Park
country: United States
facility: Research Facility
state: Kansas
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Baton Rouge
country: United States
facility: Stat-Lab I, Inc.
state: Louisiana
city: New Iberia
country: United States
facility: Research Facility
state: Louisiana
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: Frederick
country: United States
facility: Research Facility
state: Maryland
city: Brockton
country: United States
facility: Research Facility
state: Massachusetts
city: Haverhill
country: United States
facility: East Coast Clinical Research
state: Massachusetts
city: Springfield
country: United States
facility: Research Facility
state: Massachusetts
city: Bay City
country: United States
facility: Research Facility
state: Michigan
city: Biloxi
country: United States
facility: Premier Internal Medicine
state: Mississippi
city: Florissant
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: Sports Med Consultants PC
state: Missouri
city: Henderson
country: United States
facility: Research Facility
state: Nevada
city: New York
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: Morgantown
country: United States
facility: Research Facility
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Facility
state: North Carolina
city: Canton
country: United States
facility: Research Facility
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Columbus
country: United States
facility: Research Facility
state: Ohio
city: Columbus
country: United States
facility: Research Facility
state: Ohio
city: Dayton
country: United States
facility: Digestive Endoscopy Center
state: Ohio
city: Dayton
country: United States
facility: Research Facility
state: Ohio
city: Middleburg Heights
country: United States
facility: Research Facility
state: Ohio
city: Mt. Gilead
country: United States
facility: Research Facility
state: Ohio
city: Toledo
country: United States
facility: Research Facility
state: Ohio
city: Oklahoma City
country: United States
facility: Research Facility
state: Oklahoma
city: Eugene
country: United States
facility: Research Facility
state: Oregon
city: Medford
country: United States
facility: Research Facility
state: Oregon
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Research Facility
state: Pennsylvania
city: Lancaster
country: United States
facility: Oyster Point Family Health Ctr
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Research Facility
state: Pennsylvania
city: West Reading
country: United States
facility: Research Facility
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Cranston
country: United States
facility: Research Facility
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Pharmaceutical Research
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic, PLLC
state: Tennessee
city: Austin
country: United States
facility: Research Facility
state: Texas
city: Colleyville
country: United States
facility: Research Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Nederland
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Sugarland
country: United States
facility: Research Facility
state: Texas
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: Norfolk
country: United States
facility: NDC Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Independence Family Medicine
state: Virginia
city: Tacoma
country: United States
facility: Pacific Northwest Primary Care
state: Washington
Study officials:
References: