Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
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.
|Chronic Low Back Pain||Drug: Bicifadine Drug: Standard of Care (pharmacological analgesic treatment)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain|
- Adverse Events
- Clinical Labs
- Vital Signs
- Pain Severity Rating (VAS)
- Short-Form McGill Pain Questionnaire (SF-MPQ)
- Roland-Morris Disability Questionnaire (RDQ)
- Short-Form 36 (SF-36) Health Survey
- Patient Withdrawal Checklist
|Study Start Date:||December 2004|
There are two ways by which subjects could enter this study.
Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine (Studies 020 and 021, both in the United States) could roll over into this study.
Also, de novo subjects (that is, subjects who had not previously received bicifadine) could enroll in this study.
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