A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.

Trial Profile

A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2014

At a glance

  • Drugs Mesalazine (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Shire
  • Most Recent Events

    • 12 May 2011 New trial record
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