Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Summary

To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.

Timeline

Start

2010-11

Primary completion

2013-01

Completion

2013-03

Publications

• Sun J, Yuan Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):410-22. doi: 10.1007/s12325-016-0304-y. Epub 2016 Feb 23.

Drugs

Indications