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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295711
• Other study ID #: DOV-075-020
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: June 22, 2006
• Start date: September 2004

Study information

• Verified date: June 2006
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

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 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.

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)Physician’s Global Impression of Change (7-point categorical scale)
Secondary	Patient’s Global Evaluation of Study Medication (5-point categorical scale)
Secondary	Physician’s Global Evaluation of Study Medication (5-point categorical scale)
Secondary	Incidence of study discontinuation due to lack of efficacy
Secondary	Plasma PK of bicifadine