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

Summary

The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain. The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.

Timeline

Start

2004-09

Primary completion

—

Completion

—

Drugs

Indications