Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Bicifadine
* Drug: Standard of Care (pharmacological analgesic treatment)


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicifadine|nan|
|Drug: Standard of Care (pharmacological analgesic treatment)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  |  | 
| Clinical Labs |  |  | 
| Vital Signs |  |  | 
| ECGs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |