drugset / Trial / NCT00232258

Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study

NCT00232258 ↗

Phase 2 Completed 307 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.

Timeline

Start
2005-04
Primary completion
2006-09
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Nolpitantium Small molecule 600 mg —
Subject Nolpitantium Small molecule 1800 mg —

Indications