Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.