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

Chronic Low Back Pain Clinical Trial

Official title:
A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00295724
Study type Interventional
Source DOV Pharmaceutical, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 2005
View Details
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