Status:
COMPLETED
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Lead Sponsor:
DOV Pharmaceutical, Inc.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 modera...
Eligibility Criteria
Inclusion
- Main
- Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination.
- Patients must have required on average daily analgesics for the treatment of low back pain for at least 3 months prior to dosing.
- Main
Exclusion
- Patients may not have moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity).
- Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline.
- Patients may not have an unstable medical condition.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00295711
Start Date
September 1 2004
Last Update
June 23 2006
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