Status:
COMPLETED
Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study
Lead Sponsor:
Sanofi
Conditions:
Ulcerative Colitis
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 col...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00232258
Start Date
April 1 2005
End Date
September 1 2006
Last Update
December 10 2008
Active Locations (14)
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1
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
São Paulo, Brazil
4
Sanofi-Aventis Administrative Office
Laval, Canada