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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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