Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

Stopped early · Phase 3

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01135524

Run by

Purdue Pharma LP

People needed

196

Starts

2004-04-01

Expected to finish

2005-08-01

Last updated by the study team

2012-09-10

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Facility — Birmingham, Alabama, United States
• The Birmingham Pain Center — Birmingham, Alabama, United States
• University of Alabama Hospital — Birmingham, Alabama, United States
• HealthSouth Metro West Hospital — Fairfield, Alabama, United States
• Research Facility — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Research Facility — Phoenix, Arizona, United States
• Research Facility — Tucson, Arizona, United States
• Hot Springs Pain Clinic — Hot Springs, Arkansas, United States
• Research Facility — Buena Park, California, United States
• Research Facility — Chula Vista, California, United States
• Research Facility — Fresno, California, United States
• Research Facility — Los Gatos, California, United States
• Research Facility — Roseville, California, United States
• NTOUCH Research Corporation — San Diego, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — Torrence, California, United States
• Research Facility — Upland, California, United States
• Research Facility — Pueblo, Colorado, United States
• Research Facility — Bridgeport, Connecticut, United States
• Research Facility — Coral Gables, Florida, United States
• Research Facility — Daytona Beach, Florida, United States
• Research Facility — Hialeah, Florida, United States
• Research Facility — Jupiter, Florida, United States
• Alabama Neurology and Pain Medicine — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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