Clinical trial NCT00312221: Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
Official title: Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis, opioid, transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-07
Enrollment: 418
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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release 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, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over twenty-five 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, confirmed by radiographic evidence within the last 2 years.
* Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

Exclusion Criteria:

* Not currently taking and tolerating opioids.
* Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
* Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
timeFrame: Weeks 4, 8, and 12 of the double-blind phase
Secondary outcomes:
measure: The Mean Daily Number of Supplemental Analgesic Medication Tablets
timeFrame: Double-blind phase (84 days)
measure: The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
timeFrame: Weeks 4, 8 and 12 of the double-blind phase
measure: The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
timeFrame: Weeks 4, 8, and 12 of the Double-blind Phase
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: San Diego
country: United States
facility: Accelovance
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research
state: California
city: Pueblo
country: United States
facility: Southern Colorado Clinic
state: Colorado
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: International Medical Research
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Marietta
country: United States
facility: Georgia Medical Research Institute
state: Georgia
city: Marietta
country: United States
facility: Non- Surgical Orthopedic & Spine Center, P.C.
state: Georgia
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Benzonia
country: United States
facility: Professional Clinical Research Crystal Lake Health Center
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology PC
state: Michigan
city: Greensboro
country: United States
facility: Pharm Quest
state: North Carolina
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Hurst
country: United States
facility: Med Search Professional Group/Pharmaceutical C-Trials Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates
state: Texas
Study officials:
References: