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Sponsored by: |
DOV Pharmaceutical, Inc. |
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Information provided by: | DOV Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00295711 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Low Back Pain |
Drug: Bicifadine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 Mg BID, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain |
Estimated Enrollment: | 532 |
Study Start Date: | September 2004 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Study ID Numbers: | DOV-075-020 |
Study First Received: | February 23, 2006 |
Last Updated: | June 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00295711 |
Health Authority: | United States: Food and Drug Administration |
bicifadine chronic low back pain |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Nervous System Diseases |