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

This study has been completed.
Sponsor:
Information provided by:
DOV Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00281645
First received: January 23, 2006
Last updated: March 26, 2007
Last verified: March 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by DOV Pharmaceutical, Inc.:

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

Estimated Enrollment: 1250
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00281645     History of Changes
Other Study ID Numbers: DOV-075-022
Study First Received: January 23, 2006
Last Updated: March 26, 2007
Health Authority: United States: Food and Drug Administration
Guatemala: Ministry of Health
India: Ministry of Health
Israel: Ministry of Health

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014