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

NCT00281645 | Completed Phase 3

• 1 other identifier: DOV-075-022
• Study Type: interventional
• Target: 1,250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Adverse Events

• Clinical Labs

• Vital Signs

• ECGs

Secondary Outcomes (5)

• 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

Interventions

Bicifadine DRUG

Standard of Care (pharmacological analgesic treatment) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DOV Pharmaceutical, Inc.: lead

MeSH Terms

Interventions

bicifadine; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 25, 2006
• Study Start: December 1, 2004
• Last Updated: March 27, 2007

Record last verified: 2007-03