OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Summary

To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis

Timeline

Start

2005-07

Primary completion

—

Completion

2006-06

Outcome

Met primary endpoint

paper achieved clinical remission (p<0.0001 for non-inferiority). PMID 18832520 ↗

Publications

• Results Kruis W, Kiudelis G, Racz I, Gorelov IA, Pokrotnieks J, Horynski M, Batovsky M, Kykal J, Boehm S, Greinwald R, Mueller R; International Salofalk OD Study Group. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009 Feb;58(2):233-40. doi: 10.1136/gut.2008.154302. Epub 2008 Oct 2.

Drugs

Indications