Completed
A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain
Led by DOV Pharmaceutical, Inc. · Updated on 2007-03-27
1250
Participants Needed
N/A
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400 mg BID for up to one year in patients with moderate to severe chronic low back pain. The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID.
CONDITIONS
Official Title
Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
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 over the past 3 months prior to screening.
Main
You will not qualify if you...
- 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) or weakness in the lower extremities.
- Patients must not have had epidural corticosteroid injections in the lower back within 1 month prior to baseline.
- Patients may not have an unstable medical condition.
Trial Site Locations
Site Locations not provided
Location information for this trial is currently unavailable.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here