Once daily versus three times daily mesalazine granules in active ulcerative colitis

A double-blind, double-dummy, randomised, non-inferiority trial

W. Kruis, G. Kiudelis, I. Rácz, A. Gorelov, J. Pokrotnieks, M. Horynski, M. Batovsky, J. Kykal, S. Boehm, R. Greinwald, R. Mueller

Research output: Contribution to journalArticle

141 Citations (Scopus)

Abstract

Objectives: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis. Design: A randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III noninferiority study. Setting: 54 centres in 13 countries. Patients: 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis (clinical activity index (CAI)>4 and endoscopic index ≥ 4 at baseline) were randomised and treated. Interventions: 8-week treatment with either 3 g OD or 1 g TID mesalazine granules. Main outcome measures: Clinical remission (CAI ≤ 4) at study end. Results: 380 patients were evaluable for efficacy and safety by intention-to-treat (ITT); 345 for per protocol (PP) analysis. In the ITT population, 79.1% in the OD group (n = 191) and 75.7% in the TID group (n = 189) achieved clinical remission (p

Original languageEnglish
Pages (from-to)233-240
Number of pages8
JournalGut
Volume58
Issue number2
DOIs
Publication statusPublished - Feb 2009

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Mesalamine
Ulcerative Colitis
Safety
Outcome Assessment (Health Care)
Therapeutics
Population

ASJC Scopus subject areas

  • Gastroenterology

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Once daily versus three times daily mesalazine granules in active ulcerative colitis : A double-blind, double-dummy, randomised, non-inferiority trial. / Kruis, W.; Kiudelis, G.; Rácz, I.; Gorelov, A.; Pokrotnieks, J.; Horynski, M.; Batovsky, M.; Kykal, J.; Boehm, S.; Greinwald, R.; Mueller, R.

In: Gut, Vol. 58, No. 2, 02.2009, p. 233-240.

Research output: Contribution to journalArticle

Kruis, W, Kiudelis, G, Rácz, I, Gorelov, A, Pokrotnieks, J, Horynski, M, Batovsky, M, Kykal, J, Boehm, S, Greinwald, R & Mueller, R 2009, 'Once daily versus three times daily mesalazine granules in active ulcerative colitis: A double-blind, double-dummy, randomised, non-inferiority trial', Gut, vol. 58, no. 2, pp. 233-240. https://doi.org/10.1136/gut.2008.154302
Kruis, W. ; Kiudelis, G. ; Rácz, I. ; Gorelov, A. ; Pokrotnieks, J. ; Horynski, M. ; Batovsky, M. ; Kykal, J. ; Boehm, S. ; Greinwald, R. ; Mueller, R. / Once daily versus three times daily mesalazine granules in active ulcerative colitis : A double-blind, double-dummy, randomised, non-inferiority trial. In: Gut. 2009 ; Vol. 58, No. 2. pp. 233-240.
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