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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bicifadine
Sponsored by
DOV Pharmaceutical, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring bicifadine, chronic low back pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    February 23, 2006
    Last Updated
    June 22, 2006
    Sponsor
    DOV Pharmaceutical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00295711
    Brief Title
    Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    DOV Pharmaceutical, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain
    Keywords
    bicifadine, chronic low back pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    532 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bicifadine
    Primary Outcome Measure Information:
    Title
    - Pain Severity Rating (100 mm visual analog scale)
    Secondary Outcome Measure Information:
    Title
    Short-Form McGill Pain Questionnaire (SF-MPQ)
    Title
    Roland-Morris Disability Questionnaire (RDQ)
    Title
    Short-Form 36 (SF-36) Health Survey
    Title
    Patient's Global Impression of Change (7-point categorical scale)Physician's Global Impression of Change (7-point categorical scale)
    Title
    Patient's Global Evaluation of Study Medication (5-point categorical scale)
    Title
    Physician's Global Evaluation of Study Medication (5-point categorical scale)
    Title
    Incidence of study discontinuation due to lack of efficacy
    Title
    Plasma PK of bicifadine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

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

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