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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

Page last updated: August 23, 2015

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