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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281645
• Other study ID #: DOV-075-022
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2006
• Last updated: March 26, 2007
• Start date: December 2004

Study information

• Verified date: March 2007
• Source: DOV Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGuatemala: Ministry of HealthIndia: Ministry of HealthIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Bicifadine

• Standard of Care (pharmacological analgesic treatment)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DOV Pharmaceutical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events
Primary	Clinical Labs
Primary	Vital Signs
Primary	ECGs
Secondary	Pain Severity Rating (VAS)
Secondary	Short-Form McGill Pain Questionnaire (SF-MPQ)
Secondary	Roland-Morris Disability Questionnaire (RDQ)
Secondary	Short-Form 36 (SF-36) Health Survey
Secondary	Patient Withdrawal Checklist