Status:
COMPLETED
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
Lead Sponsor:
Tillotts Pharma AG
Collaborating Sponsors:
Zeria Pharmaceutical
Conditions:
Ulcerative Colitis in Remission
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 (rate of non-emergence of bloody stool), in patients with Ulc...
Eligibility Criteria
Inclusion
- Patients with ulcerative colitis in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.
Exclusion
- Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.
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
NCT01257399
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