Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
DOV Pharmaceutical, Inc. Identifier:
First received: February 23, 2006
Last updated: January 26, 2007
Last verified: January 2007
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00295724     History of Changes
Other Study ID Numbers: DOV-075-021
Study First Received: February 23, 2006
Last Updated: January 26, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on February 25, 2015