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

NCT00295711 | Completed Phase 3

• 1 other identifier: DOV-075-020
• Study Type: interventional
• Target: 532
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain

Keywords

bicifadine; chronic low back pain

Outcome Measures

Primary Outcomes (1)

• - Pain Severity Rating (100 mm visual analog scale)

Secondary Outcomes (8)

• 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)

Interventions

Bicifadine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DOV Pharmaceutical, Inc.: lead

MeSH Terms

Interventions

bicifadine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: September 1, 2004
• Last Updated: June 23, 2006

Record last verified: 2006-06