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Study to Assess the Safety and Efficacy of Asacol (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis.

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Trial Profile

Study to Assess the Safety and Efficacy of Asacol (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

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At a glance

  • Drugs Mesalazine (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Procter & Gamble; Warner Chilcott

    • Most Recent Events

    • 22 May 2012 Results presented at Digestive Disease Week 2012.
    • 04 Apr 2012 Actual initiation date changed from Aug 2008 to Dec 2008 as reported by ClinicalTrials.gov.
    • 03 Apr 2012 Actual end date changed from Feb 2011 to Mar 2011 as reported by ClinicalTrials.gov.

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