Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

Summary

The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.

Timeline

Start

2007-10

Primary completion

2008-08

Completion

2010-08

Outcome

Missed primary endpoint

paper Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) PMID 21453882 ↗

paper with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). PMID 21453882 ↗

paper CONCLUSIONS: Once-daily 3g mesalazine administered as granules is superior to 9mg budesonide OD administered as capsules for achieving remission PMID 21453882 ↗

Publications

• Results Gross V, Bunganic I, Belousova EA, Mikhailova TL, Kupcinskas L, Kiudelis G, Tulassay Z, Gabalec L, Dorofeyev AE, Derova J, Dilger K, Greinwald R, Mueller R; International BUC-57 Study Group. 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2011 Apr;5(2):129-38. doi: 10.1016/j.crohns.2010.11.006. Epub 2010 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	9 mg	Oral
Comparator	Mesalamine	Small molecule	3 g	Oral

Indications