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

June 22, 2006 updated by: DOV Pharmaceutical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

532

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Pain Severity Rating (100 mm visual analog scale)

Secondary Outcome Measures

Outcome Measure
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)
Physician's Global Evaluation of Study Medication (5-point categorical scale)
Incidence of study discontinuation due to lack of efficacy
Plasma PK of bicifadine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DOV Pharmaceutical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (ESTIMATE)

February 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2006

Last Update Submitted That Met QC Criteria

June 22, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOV-075-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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