A phase III, randomized multi-centre, double-blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily with ASACOL [mesalazine] 1.6g/day twice daily in the maintenance of remission in patients with ulcerative colitis.
Phase of Trial: Phase III
Latest Information Update: 22 Mar 2017
At a glance
- Drugs Mesalazine (Primary)
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Sponsors Shire
- 02 Nov 2012 Planned number of patients changed from 826 to 830.
- 08 May 2012 Primary endpoint 'non-inferiority in endoscopic remission-rate at 6 months' has been met.
- 18 Jul 2011 Mesalazine has been approved in the US for maintenance of remission of Ulcerative colitis, based on the results from this trial.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History