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

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ClinicalTrials.gov Identifier: NCT00295711
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : June 23, 2006
Sponsor:
Information provided by:
DOV Pharmaceutical, Inc.

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Bicifadine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 532 participants
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, Bicifadine 300 Mg BID, and Bicifadine 400 Mg BID in the Treatment of Chronic Low Back Pain
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain




Primary Outcome Measures :
  1. - Pain Severity Rating (100 mm visual analog scale)

Secondary Outcome Measures :
  1. Short-Form McGill Pain Questionnaire (SF-MPQ)
  2. Roland-Morris Disability Questionnaire (RDQ)
  3. Short-Form 36 (SF-36) Health Survey
  4. Patient’s Global Impression of Change (7-point categorical scale)Physician’s Global Impression of Change (7-point categorical scale)
  5. Patient’s Global Evaluation of Study Medication (5-point categorical scale)
  6. Physician’s Global Evaluation of Study Medication (5-point categorical scale)
  7. Incidence of study discontinuation due to lack of efficacy
  8. Plasma PK of bicifadine


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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 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.

ClinicalTrials.gov Identifier: NCT00295711     History of Changes
Other Study ID Numbers: DOV-075-020
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: June 23, 2006
Last Verified: June 2006

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