Clinical trial NCT00312572: Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Official title: A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis, opioid, transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-10
Enrollment: 204
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
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 evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

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 or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

Exclusion Criteria:

* currently have condition requiring a stable regimen of acetaminophen (APAP).
* a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: The Percentage of Subjects Who Completed the 14-day Double-blind Phase.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Southern Drug Research
state: Alabama
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopedic Institute
state: Arizona
city: Hot Springs
country: United States
facility: Hot Springs Mercy Pain Clinic
state: Arkansas
city: Pine Bluff
country: United States
facility: Private Practice
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources
state: California
city: Buena Park
country: United States
facility: Southbay Pharma Research
state: California
city: Clovis
country: United States
facility: Community Medical Providers
state: California
city: Escondido
country: United States
facility: Kaiser Permanente
state: California
city: Santa Monica
country: United States
facility: Univ. of Southern California
state: California
city: Waterbury
country: United States
facility: Arthritis Center of CT
state: Connecticut
city: Miami Beach
country: United States
facility: Miami Beach Anesthesiology Associates
state: Florida
city: Miami
country: United States
facility: Lifespan Research Foundation, Inc.
state: Florida
city: Naples
country: United States
facility: Neuro Science and Spine Assoc.
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Association, Inc.
state: Florida
city: Boise
country: United States
facility: Intermountain Orthopaedics
state: Idaho
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Bluegrass Orthopaedics
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: New Orleans
country: United States
facility: Dolby Providers, Inc.
state: Louisiana
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Lansing
country: United States
facility: PCM Medical Services
state: Michigan
city: St. Louis
country: United States
facility: HealthCare Research LLC
state: Missouri
city: Barrington
country: United States
facility: Northeast Pain Research Center
state: New Hampshire
city: Charlotte
country: United States
facility: The Arthritis Clinic and Carolina Bone and Joint
state: North Carolina
city: Dayton
country: United States
facility: Dayton Primary and Urgent Care
state: Ohio
city: Medford
country: United States
facility: The Medford Medical Clinic
state: Oregon
city: Orangeburg
country: United States
facility: The Arthritis and Osteoporosis Center
state: South Carolina
city: Austin
country: United States
facility: CEDRA Clinical Research,
state: Texas
city: Dallas
country: United States
facility: Renaissance Clinical Research & Hypertension Clinic
state: Texas
city: Houston
country: United States
facility: Spine Care Southwest.
state: Texas
city: Richardson
country: United States
facility: KRK Medical Research
state: Texas
city: Monroe
country: United States
facility: Monroe Medical Foundation
state: Wisconsin
Study officials:
References:
citation: Ripa SR, McCarberg BH, Munera C, Wen W, Landau CJ. A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012 Jun;13(9):1229-41. doi: 10.1517/14656566.2012.667073. Epub 2012 Mar 12.