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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295724
First Posted: February 24, 2006
Last Update Posted: January 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
DOV Pharmaceutical, Inc.
  Purpose
  • 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.

Condition Intervention Phase
Chronic Low Back Pain Drug: Bicifadine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by DOV Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Pain Severity Rating (100 mm visual analog scale)

Secondary Outcome Measures:
  • 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)

Study Start Date: October 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00295724     History of Changes
Other Study ID Numbers: DOV-075-021
First Submitted: February 23, 2006
First Posted: February 24, 2006
Last Update Posted: January 30, 2007
Last Verified: January 2007

Keywords provided by DOV Pharmaceutical, Inc.:
bicifadine
chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms