drugset / Trial / NCT00553592

Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

NCT00553592 ↗

Phase 2 Unknown 336 enrolled XTL Biopharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients. To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.

Timeline

Start
2007-09
Primary completion
—
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bicifadine Small molecule 600 mg —
Subject Bicifadine Small molecule 1200 mg —