Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain

Study Overview
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Brief Summary
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The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo in patients with moderate to severe chronic low back pain. The secondary objectives are to investigate the dose-response relationship of three dose levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to evaluate the effect of bicifadine on function and general quality of life, to describe the population pharmacokinetics of bicifadine in patients with chronic low back pain, and to evaluate safety following discontinuation of bicifadine treatment.

Official Title
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A Multi-Center Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 Mg BID, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Bicifadine


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 for at least 3 months prior to dosing. 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicifadine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Pain Severity Rating (100 mm visual analog scale) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form McGill Pain Questionnaire (SF-MPQ) |  |  | 
| Roland-Morris Disability Questionnaire (RDQ) |  |  | 
| Short-Form 36 (SF-36) Health Survey |  |  | 
| Patient's Global Impression of Change (7-point categorical scale)Physician's Global Impression of Change (7-point categorical scale) |  |  | 
| Patient's Global Evaluation of Study Medication (5-point categorical scale) |  |  | 
| Physician's Global Evaluation of Study Medication (5-point categorical scale) |  |  | 
| Incidence of study discontinuation due to lack of efficacy |  |  | 
| Plasma PK of bicifadine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bicifadine, chronic low back pain