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

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ClinicalTrials.gov Identifier: NCT00281645
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : March 27, 2007
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Bicifadine Drug: Standard of Care (pharmacological analgesic treatment) Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Adverse Events
  2. Clinical Labs
  3. Vital Signs
  4. ECGs

Secondary Outcome Measures :
  1. Pain Severity Rating (VAS)
  2. Short-Form McGill Pain Questionnaire (SF-MPQ)
  3. Roland-Morris Disability Questionnaire (RDQ)
  4. Short-Form 36 (SF-36) Health Survey
  5. Patient Withdrawal Checklist

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
More Information

ClinicalTrials.gov Identifier: NCT00281645     History of Changes
Other Study ID Numbers: DOV-075-022
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: March 27, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs