Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis P. R. GIBSON*, B. FIXA  , B. PEKA ´ RKOVA ´ à , M. BA ´ TOVSKY ´ §, G. RADFORD-SMITH – , J. TIBITANZL**, L. GABALEC   , T. H. J. FLORIN àà & R. GREINWALD§§ *The Royal Melbourne Hospital, Mel- bourne, Vic, Australia;  University Hospital, Hradec Kralove, Czech Republic; àPrivate Gastroenterology Centre, Trnava, Slovakia; §FNsP ak. Derera III: interni klinika, Limbova ´, Bratislava, Slovakia; –Royal Brisbane Hospital, Herston, Qld, Australia; **Nemocnice Hranice a.s., Hranice na Morave, Czech Republic;   District Hospital, Usti nad Orlici, Czech Republic; ààMater Health Services Adult Hospital, South Brisbane, Qld, Australia; §§Dr Falk Pharma GmbH, Freiburg, Baden-Wu ¨ rttemberg, Germany Correspondence to: Professor P. Gibson, Department of Gastroenterology, Box Hill Hospital, Victoria 3128, Australia. E-mail: peter.gibson@ med.monash.edu.au Publication data Submitted 16 December 2005 First decision 11 January 2006 Resubmitted 30 January 2006 Accepted 30 January 2006 SUMMARY Background There are no comparative studies of coated mesalazine. Aim To compare the efficacy and tolerability of Eudragit-L- and ethylcellu- lose-coated mesalazine tablets in patients with mild to moderately act- ive ulcerative colitis. Methods A double-blind, double-dummy, randomized parallel group trial was performed across 18 centres in Australia, and 20 in Eastern Europe. Patients were treated with 3 g mesalazine for 8 weeks with the primary efficacy end point being clinical remission. Results Of 215 patients, 69% achieved clinical remission in both treatment groups (P < 0.001; chi-square test) with no differences in frequency of adverse events. In the Australian cohort (n ¼ 63), the Eudragit-L group had a higher remission rate (73% vs. 36%) and responded 13 days fas- ter, compared with those in the European group (67% vs. 84%, and 2 days respectively). No clear reasons for differences in treatment responses were identified. Conclusions Eudragit-L and ethylcellulose-coated mesalazine tablets are well toler- ated and equally effective in achieving remission in mild-moderately active ulcerative colitis over 8 weeks. Aliment Pharmacol Ther 23, 1017–1026 Alimentary Pharmacology & Therapeutics ª 2006 The Authors 1017 Journal compilation ª 2006 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2006.02861.x