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

Phase 3 Completed 343 enrolled Shire

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo

Timeline

Start: 2003-12-04
Primary completion: 2004-10-20
Completion: 2004-10-20

Outcome

Met primary endpoint

paper A significantly greater proportion of patients receiving MMX mesalamine 2.4 g/day given once daily (40.5%; P = .01) PMID 17241860 ↗

paper achieved clinical and endoscopic remission at week 8, vs placebo (22.1%). PMID 17241860 ↗

Publications

Results Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	2.4 g	Oral
Subject	Mesalamine	Small molecule	4.8 g	Oral