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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295724
• Other study ID #: DOV-075-021
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: January 26, 2007
• Start date: October 2005

Study information

• Verified date: January 2007
• Source: DOV Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Bicifadine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DOV Pharmaceutical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity Rating (100 mm visual analog scale)
Secondary	Short-Form McGill Pain Questionnaire (SF-MPQ)
Secondary	Roland-Morris Disability Questionnaire (RDQ)
Secondary	Short-Form 36 (SF-36) Health Survey
Secondary	Patient's Global Impression of Change (7-point categorical scale)