Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study (NICE)

NCT00232258 Phase 2 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 2
Status	COMPLETED
Enrolment	307
Start date	2005-04
Completion	2006-09

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Disease

Interventions

• Nolpitantium besylate

Primary outcomes

• Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1

Countries

Argentina, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Hungary, Italy, Russia, Singapore, South Africa, Spain, Sweden