Status:
COMPLETED
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Lead Sponsor:
Tillotts Pharma AG
Collaborating Sponsors:
Zeria Pharmaceutical
Conditions:
Active Ulcerative Colitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative...
Eligibility Criteria
Inclusion
- Patients with Ulcerative Colitis (UC) at active phase who are defined to show Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher
Exclusion
- Patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01257386
Start Date
November 1 2010
End Date
March 1 2013
Last Update
April 4 2013
Active Locations (1)
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1
Shanghai Hospital
Shanghai, China