Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

• Status: Completed
• Trial end date: 2005-01-17
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis

• women not of childbearing potential or WOCP who agreed to use an effective contraceptive method

Exclusion Criteria:

• severe ulcerative colitis or relapsed for > 6 weeks prior to baseline

• subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day

• subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease

• subjects with asthma if they were known to be mesalazine-sensitive

• subjects who were at immediate or significant risk of toxic megacolon

• subjects who had previous resective colonic surgery

• subjects who had moderate or severe renal impairment