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

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.

Timeline

Start

2003-09-30

Primary completion

2005-01-17

Completion

2005-01-17

Publications

• Results Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, Butler T, Lees K, Joseph RE, Sandborn WJ. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007 Jan;5(1):95-102. doi: 10.1016/j.cgh.2006.10.025.

Drugs

Indications