Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

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.

Timeline

Start

2010-11

Primary completion

2012-08

Completion

2013-03

Publications

• Sun J, Yuan Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):400-9. doi: 10.1007/s12325-016-0303-z. Epub 2016 Feb 22.

Drugs

Indications