Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastric Ulcer / 대한소화기내시경학회지
Korean Journal of Gastrointestinal Endoscopy
;
: 312-319, 2007.
Artigo
em Coreano
| WPRIM
| ID: wpr-192078
ABSTRACT
BACKGROUND/AIMS:
This randomized, double-blind, phase III, multicenter trial was carried out to compare the efficacy and safety of revaprazan, a novel acid pump antagonist, with that of omeprazole in patients with more than one of gastric ulcers.METHODS:
Two hundred and ninety two subjects were randomized to 4~8 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg. The primary efficacy parameter was the cumulative healing rate determined by endoscopy after 4 and 8 weeks of treatment, and the secondary efficacy parameter was an improvement rate of pain.RESULTS:
The intention-to-treat analysis revealed revaprazan and omeprazole to have similar cumulative healing rates (93.0% and 89.6%, respectively; p=0.3038). The per-protocol analysis revealed revaprazan and omeprazole to also have similar cumulative healing rates (99.1% and 100%, respectively; p= 0.3229). In both analyses, there were no significant differences in an improvement rate of pain between the two groups. Both drugs were well tolerated.CONCLUSIONS:
Revaprazan has similar efficacy to omeprazole in the treatment of patients with gastric ulcer with a once a day application of revaprazan 200 mg or omeprazole 20 mg over a 4 to 8-week period. In terms of safety, revaprazan was well tolerated.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Úlcera Gástrica
/
Omeprazol
/
Endoscopia
Tipo de estudo:
Ensaio Clínico Controlado
/
Guia de Prática Clínica
Limite:
Humanos
Idioma:
Coreano
Revista:
Korean Journal of Gastrointestinal Endoscopy
Ano de publicação:
2007
Tipo de documento:
Artigo
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