drugset / Trial / NCT00295724

Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain

NCT00295724 ↗

Phase 3 Completed DOV Pharmaceutical, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

* The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain. * The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life, to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine.

Timeline

Start
2005-10
Primary completion
—
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicifadine Small molecule 200 mg —

Indications