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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion Criteria:

• Age at least 18 years

• Ulcerative colitis of at least 6 months duration

• Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week

• If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and not exceed 20 mg per day (prednisolone equivalent)

Exclusion Criteria:

• Crohn's disease

• Colonic dysplasia

• Stool culture positive for enteric pathogens

• Concurrent cancer or unstable medical condition

• Recent treatment with monoclonal antibody

• Recent introduction of thiazolidinedione

• Recent treatment with methotrexate or cyclosporine

• Recent treatment with an antibiotic prescribed for ulcerative colitis