Clinical trial NCT01141283: Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Opioid
Transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-06-10
Enrollment: 290
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility criteria: Inclusion Criteria:

* Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria:

* Excluded from the study are subjects who ingest \> 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
* Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.

Primary outcomes:
measure: The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Vista Medical Research Inc.
state: Arizona
city: Phoenix
country: United States
facility: Arthrocare, Arthritis Care and Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: Research Facility
state: Arizona
city: Bakersfield
country: United States
facility: Advanced Pain Medicine
state: California
city: Cypress
country: United States
facility: Orange County Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Arthritis & Osteoporosis Medical Clinic
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: San Francisco
country: United States
facility: Research Facility
state: California
city: Denver
country: United States
facility: Research Facility
state: Colorado
city: Westminster
country: United States
facility: Research Facility
state: Colorado
city: Bridgeport
country: United States
facility: Research Facility
state: Connecticut
city: Atlantis
country: United States
facility: Research Facility
state: Florida
city: Daytona Beach
country: United States
facility: Allergy, Asthma, Arthritis & Lung
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland
state: Florida
city: Jupiter
country: United States
facility: Research Facility
state: Florida
city: Orange City
country: United States
facility: Coastal Medical Research
state: Florida
city: Plantation
country: United States
facility: Research Facility
state: Florida
city: West Palm Beach
country: United States
facility: Research Facility
state: Florida
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Columbus
country: United States
facility: Research Facility
state: Indiana
city: Evansville
country: United States
facility: Research Facility
state: Indiana
city: Murray
country: United States
facility: Primary Care Medical Center
state: Kentucky
city: Cadillac
country: United States
facility: Great Lakes Family Care
state: Michigan
city: Traverse City
country: United States
facility: Research Facility
state: Michigan
city: New York
country: United States
facility: Beth Israel/Dept. of Pain
state: New York
city: Winston-Salem
country: United States
facility: Research Facility
state: North Carolina
city: Cresson
country: United States
facility: Research Facility
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics & Sport Medicine Center
state: Pennsylvania
city: West Reading
country: United States
facility: Research Facility
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Watertown
country: United States
facility: Central Plains Clin-Brown Site
state: South Dakota
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Harker Heights
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Seguin
country: United States
facility: Research Facility
state: Texas
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Virginia Beach
country: United States
facility: Hilltop Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Research Facility
state: Washington
city: Tacoma
country: United States
facility: Internal Medicine Northwest
state: Washington
Study officials:
References: