Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Information source: Tillotts Pharma AG
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Active Ulcerative Colitis
Intervention: Asacol® (Drug); Mesalazine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Tillotts Pharma AG
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 colitis (UC) treated for 8 weeks.
Clinical Details
Official title: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Reduction degree of UC-DAI
Secondary outcome: 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Shanghai Hospital, Shanghai, China
Additional Information
Starting date: November 2010
Last updated: April 3, 2013
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