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

Completed · Phase 3

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT00503243

Run by

Shire

People needed

280

Starts

2003-09-30

Expected to finish

2005-01-17

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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