NCT00232258

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with active mild to moderate ulcerative colitis that has not responded to a minimum of 4 weeks of 5-ASA will be randomized to receive single daily doses of either placebo, 600 mg SR140333B or 1800 mg of SR140333B for eight weeks. Patients will undergo baseline and end of study sigmoidoscopic assessments and complete daily symptom diaries during the study. Ulcerative colitis disease activity will be measured by both the overall and component subscores of the Mayo Disease Activity Index.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Nolpitantium besylate

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-10-04
• Last updated: 2008-12-10

Locations

14 sites across 14 countries: Argentina, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Hungary, Italy, Russia, Singapore, South Africa, Spain, Sweden