Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
CompletedPhase 3NCT00281645
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Drug: Bicifadine
- Drug: Standard of Care (pharmacological analgesic treatment)
- Sponsor
- DOV Pharmaceutical, Inc.
- Start date
- 2004-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00281645