Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

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

Key facts

Study ID

NCT01141283

Run by

Purdue Pharma LP

People needed

290

Starts

2003-04-01

Expected to finish

2004-07-01

Last updated by the study team

2012-09-03

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vista Medical Research Inc. — Mesa, Arizona, United States
• Arthrocare, Arthritis Care and Research — Phoenix, Arizona, United States
• Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Research Facility — Tucson, Arizona, United States
• Advanced Pain Medicine — Bakersfield, California, United States
• Orange County Clinical Research — Cypress, California, United States
• San Diego Arthritis & Osteoporosis Medical Clinic — San Diego, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — San Francisco, California, United States
• Research Facility — Denver, Colorado, United States
• Research Facility — Westminster, Colorado, United States
• Research Facility — Bridgeport, Connecticut, United States
• Research Facility — Atlantis, Florida, United States
• Allergy, Asthma, Arthritis & Lung — Daytona Beach, Florida, United States
• University Clinical Research Deland — DeLand, Florida, United States
• Research Facility — Jupiter, Florida, United States
• Coastal Medical Research — Orange City, Florida, United States
• Research Facility — Plantation, Florida, United States
• Research Facility — West Palm Beach, Florida, United States
• Research Facility — Marietta, Georgia, United States
• Research Facility — Columbus, Indiana, United States
• Research Facility — Evansville, Indiana, United States
• Primary Care Medical Center — Murray, Kentucky, United States
• Great Lakes Family Care — Cadillac, Michigan, United States

Full record on ClinicalTrials.gov

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