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.
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
- 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.