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, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295711

Enrollment

532

Registered

2006-02-24

Start date

2004-09-30

Completion date

Unknown

Last updated

2006-06-23

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 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.

Interventions

DRUGBicifadine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—
Short-Form McGill Pain Questionnaire (SF-MPQ)	—
Physician's Global Evaluation of Study Medication (5-point categorical scale)	—
Incidence of study discontinuation due to lack of efficacy	—
Plasma PK of bicifadine	—
Patient's Global Evaluation of Study Medication (5-point categorical scale)	—

Outcome results

None listed

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