Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.