Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Tillotts Pharma AG251 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

251

Conditions

Active Ulcerative Colitis

Interventions

Asacol®DRUG

400mg tablets

MesalazineDRUG

400mg tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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 (1)

Shanghai Hospital

Shanghai, China

Outcomes

Primary Outcomes

Reduction degree of UC-DAI

Time frame: Week 8

Secondary Outcomes

1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate

Time frame: Week 8

Data from ClinicalTrials.gov

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