Clinical trial NCT01135524: Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase
Official title: A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Opioid
Transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 196
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

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:

* Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.

Exclusion Criteria:

* Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
* Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
* 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: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Alabama Neurology and Pain Medicine
state: Alabama
city: Birmingham
country: United States
facility: Research Facility
state: Alabama
city: Birmingham
country: United States
facility: The Birmingham Pain Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Fairfield
country: United States
facility: HealthSouth Metro West Hospital
state: Alabama
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Tucson
country: United States
facility: Research Facility
state: Arizona
city: Hot Springs
country: United States
facility: Hot Springs Pain Clinic
state: Arkansas
city: Buena Park
country: United States
facility: Research Facility
state: California
city: Chula Vista
country: United States
facility: Research Facility
state: California
city: Fresno
country: United States
facility: Research Facility
state: California
city: Los Gatos
country: United States
facility: Research Facility
state: California
city: Roseville
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: NTOUCH Research Corporation
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: Torrence
country: United States
facility: Research Facility
state: California
city: Upland
country: United States
facility: Research Facility
state: California
city: Pueblo
country: United States
facility: Research Facility
state: Colorado
city: Bridgeport
country: United States
facility: Research Facility
state: Connecticut
city: Coral Gables
country: United States
facility: Research Facility
state: Florida
city: Daytona Beach
country: United States
facility: Research Facility
state: Florida
city: Hialeah
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: Research Facility
state: Florida
city: North Miami Beach
country: United States
facility: Research Facility
state: Florida
city: Ocala
country: United States
facility: Research Facility
state: Florida
city: Ormond Beach
country: United States
facility: Research Facility
state: Florida
city: Palm Harbor
country: United States
facility: Research Facility
state: Florida
city: Pembroke Pines
country: United States
facility: Research Facility
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Plantation
country: United States
facility: Research Facility
state: Florida
city: Port Orange
country: United States
facility: Research Facility
state: Florida
city: Tampa
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: Boise
country: United States
facility: Research Facility
state: Idaho
city: Meridian
country: United States
facility: Idaho Arthritis Osteoporosis
state: Idaho
city: Chicago
country: United States
facility: Research Facility
state: Illinois
city: Springfield
country: United States
facility: Research Facility
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trials
state: Iowa
city: Louisville
country: United States
facility: Louisville Endocrinology PSC
state: Kentucky
city: Madisonville
country: United States
facility: Research Facility
state: Kentucky
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: New Orleans
country: United States
facility: Dolby Providers
state: Louisiana
city: Baltimore
country: United States
facility: Research Facility
state: Maryland
city: Columbia
country: United States
facility: Patuxent Medical Group
state: Maryland
city: Hagerstown
country: United States
facility: Research Facility
state: Maryland
city: Brockton
country: United States
facility: Research Facility
state: Massachusetts
city: Benzonia
country: United States
facility: Crystal Lake Health Center
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology PC
state: Michigan
city: Lansing
country: United States
facility: Research Facility
state: Michigan
city: Independence
country: United States
facility: KC Pain Centers East
state: Missouri
city: St. Louis
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: HealthCare Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Research Facility
state: Nevada
city: Las Vegas
country: United States
facility: Research Facility
state: Nevada
city: New York
country: United States
facility: Research Facility
state: New York
city: Syracuse
country: United States
facility: Research Facility
state: New York
city: Charlotte
country: United States
facility: The Arthritis Clinic and Carolina Bone and Joint
state: North Carolina
city: Durham
country: United States
facility: Triangle Orthopaedic Associates
state: North Carolina
city: Greensboro
country: United States
facility: Research Facility
state: North Carolina
city: Hickory
country: United States
facility: Research Facility
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Columbus
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: Altoona
country: United States
facility: Research Facility
state: Pennsylvania
city: Duncansville
country: United States
facility: Research Facility
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Research Facility
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Amarillo
country: United States
facility: Allergy ARTS
state: Texas
city: Conroe
country: United States
facility: Research Facility
state: Texas
city: Corpus Christi
country: United States
facility: Family Practice Associates
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Houston
country: United States
facility: Research Facility
state: Texas
city: Richardson
country: United States
facility: KRK Medical Research
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: Spokane
country: United States
facility: Research Facility
state: Washington
city: Milwaukee
country: United States
facility: Research Facility
state: Wisconsin
city: New Berlin
country: United States
facility: Research Facility
state: Wisconsin
Study officials:
References: