drugset / Trial / NCT00597649

A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

NCT00597649 ↗

Phase 2 Terminated 250 enrolled XTL Biopharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Timeline

Start
2007-10
Primary completion
2008-12
Completion
2008-12

Outcome

Outcome not reported

Stopped: “The 001 trial did not show benefit versus placebo”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicifadine Small molecule 800 mg —
Subject Bicifadine Small molecule 1200 mg —