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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 23, 2006
Last Updated Date	January 26, 2007
Start Date ^ICMJE	October 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2006)	Pain Severity Rating (100 mm visual analog scale)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00295724 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 23, 2006)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Official Title ^ICMJE	A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Chronic Low Back Pain
Intervention ^ICMJE	Drug: Bicifadine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00295724
Other Study ID Numbers ^ICMJE	DOV-075-021
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	DOV Pharmaceutical, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	DOV Pharmaceutical, Inc.
Verification Date	January 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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