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+ years
Phase:
PHASE3
Brief 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 ...
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 with pain categorized as Class 1 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of \>17 at baseline to qualify. Patients with pain categorized as Class 2 or Class 3 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of at least 10 at baseline to qualify.
- Patients must have required daily analgesics for the treatment of low back pain for at least 3 months prior dosing.
- Main
Exclusion
- Patients may not have persistent 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 :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00295724
Start Date
October 1 2005
Last Update
January 30 2007
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