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Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bicifadine
Standard of Care (pharmacological analgesic treatment)
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

Eligibility Criteria

18 Years - undefined (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 over the past 3 months prior to screening. 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) or weakness in the lower extremities. Patients must not have had epidural corticosteroid injections in the lower back within 1 month prior to baseline. Patients may not have an unstable medical condition.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Adverse Events
    Clinical Labs
    Vital Signs
    ECGs

    Secondary Outcome Measures

    Pain Severity Rating (VAS)
    Short-Form McGill Pain Questionnaire (SF-MPQ)
    Roland-Morris Disability Questionnaire (RDQ)
    Short-Form 36 (SF-36) Health Survey
    Patient Withdrawal Checklist

    Full Information

    First Posted
    January 23, 2006
    Last Updated
    March 26, 2007
    Sponsor
    DOV Pharmaceutical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00281645
    Brief Title
    Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
    Official Title
    A Multicenter Standard of Care-Controlled Study to Evaluate the Long-Term Safety of Bicifadine for the Treatment of Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    December 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 objective of the study is to evaluate the safety and efficacy of bicifadine 400 mg BID for up to one year in patients with moderate to severe chronic low back pain. The secondary objectives are to compare the long-term safety of bicifadine to standard of care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not tolerate bicifadine 400 mg BID.
    Detailed Description
    There are two ways by which subjects could enter this study. Subjects who completed 12 weeks of treatment in two other double blind clinical studies of bicifadine (Studies 020 and 021, both in the United States) could roll over into this study. Also, de novo subjects (that is, subjects who had not previously received bicifadine) could enroll in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1250 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bicifadine
    Intervention Type
    Drug
    Intervention Name(s)
    Standard of Care (pharmacological analgesic treatment)
    Primary Outcome Measure Information:
    Title
    Adverse Events
    Title
    Clinical Labs
    Title
    Vital Signs
    Title
    ECGs
    Secondary Outcome Measure Information:
    Title
    Pain Severity Rating (VAS)
    Title
    Short-Form McGill Pain Questionnaire (SF-MPQ)
    Title
    Roland-Morris Disability Questionnaire (RDQ)
    Title
    Short-Form 36 (SF-36) Health Survey
    Title
    Patient Withdrawal Checklist

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 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 over the past 3 months prior to screening. 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) or weakness in the lower extremities. Patients must not have had epidural corticosteroid injections in the lower back within 1 month prior to baseline. Patients may not have an unstable medical condition.

    12. IPD Sharing Statement

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