3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F11%3A33145784" target="_blank" >RIV/61989592:15110/11:33145784 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.crohns.2010.11.006" target="_blank" >http://dx.doi.org/10.1016/j.crohns.2010.11.006</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.crohns.2010.11.006" target="_blank" >10.1016/j.crohns.2010.11.006</a>
Alternative languages
Result language
angličtina
Original language name
3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.
Original language description
BACKGROUND AND AIMS: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD. METHODS: This wasan eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ?6 and Endoscopic Index (EI) ?4, received budesonide (Budenofalk(R) 3mg capsulesx3) ormesalazine (Salofalk(R) 1000mg granulesx3). The primary endpoint was clinical remission at week 8 (CAI ?4 with stool frequency and rectal bleeding subscores of "0"). RESULTS: 343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FE - Other fields of internal medicine
OECD FORD branch
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Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2011
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Crohn's and Colitis
ISSN
1873-9946
e-ISSN
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Volume of the periodical
5
Issue of the periodical within the volume
2
Country of publishing house
NL - THE KINGDOM OF THE NETHERLANDS
Number of pages
10
Pages from-to
129-138
UT code for WoS article
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EID of the result in the Scopus database
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