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

This study has been completed.
Sponsor:
Information provided by:
DOV Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00295724
First received: February 23, 2006
Last updated: January 26, 2007
Last verified: January 2007

February 23, 2006
January 26, 2007
October 2005
Not Provided
Pain Severity Rating (100 mm visual analog scale)
Same as current
Complete list of historical versions of study NCT00295724 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Low Back Pain
Drug: Bicifadine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00295724
DOV-075-021
Not Provided
Not Provided
DOV Pharmaceutical, Inc.
Not Provided
Not Provided
DOV Pharmaceutical, Inc.
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP