Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Phase 3

Completed

• Conditions: Active Ulcerative Colitis
• Interventions: Drug: Asacol®; Drug: Mesalazine

• Registration Number: NCT01257386
• Lead Sponsor: Tillotts Pharma AG

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 colitis (UC) treated for 8 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2012-08
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asacol®	Asacol®	Import Mesalazine
Mesalazine	Mesalazine	Marketed Mesalazine

Primary Outcome Measures

Name	Time	Method
Reduction degree of UC-DAI	Week 8

Secondary Outcome Measures

Name	Time	Method
1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate	Week 8

Trial Locations

Locations (1)

Shanghai Hospital; 🇨🇳 Shanghai, China