Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain - Full Text View

Sponsored by:	DOV Pharmaceutical, Inc.
Information provided by:	DOV Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00295711

Purpose

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	Intervention	Phase
Chronic Low Back Pain	Drug: Bicifadine	Phase III

MedlinePlus related topics: Back Pain

Drug Information available for: Bicifadine Bicifadine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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)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

Estimated Enrollment:	532
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	DOV-075-020
Study First Received:	February 23, 2006
Last Updated:	June 22, 2006
ClinicalTrials.gov Identifier:	NCT00295711
Health Authority:	United States: Food and Drug Administration

Keywords provided by DOV Pharmaceutical, Inc.:

bicifadine
chronic low back pain

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009