Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy.

Trial Profile

Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2015

At a glance

  • Drugs Balsalazide (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Salix Pharmaceuticals
  • Most Recent Events

    • 11 Oct 2013 Results from a sub-group analysis, comparing male and female responses, will be presented at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting according to a Salix Pharmaceuticals media release.
    • 29 Dec 2009 Actual initiation date (Dec 2005) added as reported by ClinicalTrials.gov.
    • 29 Dec 2009 Actual end date (June 2007) added as reported by ClinicalTrials.gov.
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