SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

DRUG2 trials

Sponsors

Shire

Conditions

Colitis, UlcerativeUlcerative Colitis

Phase 2

Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

CompletedNCT00545389

ShireColitis, Ulcerative

Start: 2003-02-10End: 2004-10-20Updated: 2021-06-11

Phase 3

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

CompletedNCT00548574

ShireUlcerative Colitis

Start: 2003-12-04End: 2004-10-20Updated: 2021-06-11