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

A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295724

Enrollment

Unknown

Registered

2006-02-24

Start date

2005-10-31

Completion date

Unknown

Last updated

2007-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

bicifadine, chronic low back pain

Brief summary

* The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain. * The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life, to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine.

Interventions

DRUGBicifadine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 with pain categorized as Class 1 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of \>17 at baseline to qualify. Patients with pain categorized as Class 2 or Class 3 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of at least 10 at baseline to qualify. * Patients must have required daily analgesics for the treatment of low back pain for at least 3 months prior dosing. Main

Exclusion criteria

* Patients may not have persistent 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.

Design outcomes

Primary

Measure	Time frame
Pain Severity Rating (100 mm visual analog scale)	—

Secondary

Measure	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)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026