Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

Stopped early · Phase 3

Conditions studied: Back Pain Lower Back Chronic

In brief

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

Key facts

Study ID

NCT01125917

Run by

Purdue Pharma LP

People needed

354

Starts

2004-06-01

Expected to finish

2008-01-01

Last updated by the study team

2012-09-03

Who can join

Age: 18 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.
• For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase

You may not qualify if…

• Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Where it is running

• Arthritis Clinical Intervention Program — Birmingham, Alabama, United States
• Winston Physician Services, Inc — Haleyville, Alabama, United States
• Arizona Research Center Inc — Phoenix, Arizona, United States
• Radiant Research — Phoenix, Arizona, United States
• Advanced Clinical Therapeutics — Tucson, Arizona, United States
• Hot Springs Pain Clinic — Hot Springs, Arkansas, United States
• NuLife Clinical Research, Inc. — Anaheim, California, United States
• Lovelace Scientific Resources — Beverly Hills, California, United States
• Northern California Research Corp — Carmichael, California, United States
• International Clinical Research Network — Chula Vista, California, United States
• Shreenath Clinical Service — Fountain Valley, California, United States
• U of Calif at Davis, Med Ctr, Pain Management Center — Sacramento, California, United States
• Accelovance — San Diego, California, United States
• Southern Colorado Clinic — Pueblo, Colorado, United States
• Chiefland Medical Center — Chiefland, Florida, United States
• University Clinical Research Deland — DeLand, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Innovative Research of West Florida, Inc. — Largo, Florida, United States
• Renstar Medical — Ocala, Florida, United States
• Peninsula Research Inc. — Ormond Beach, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Gold Coast Research, LLC — Plantation, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Birmingham Pain Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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