Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastric Ulcer.
- Author:
Rin CHANG
1
;
In Sik CHUNG
;
Soo Heon PARK
;
Sung Kook KIM
;
Seok Reyol CHOI
;
Geun Am SONG
;
Ki Baik HAHM
;
Yong Chan LEE
;
Hyun Soo KIM
;
Tae Nyeun KIM
;
Suck Chei CHOI
;
Sang Yong SEOL
;
Jong Sun REW
;
Dong Joon KIM
;
Jin LEE
;
Ho Soon CHOI
;
Jung Eun LEE
;
Geun Seog SONG
;
Byoung Seok MOON
;
Sang Aun JOO
Author Information
1. Department of Gastroenterology, Kyunghee University College of Medicine, Seoul, Korea. kmcim@chollian.net
- Publication Type:Clinical Trial ; Randomized Controlled Trial ; Original Article ; Multicenter Study
- Keywords:
Revaprazan;
Omeprazole;
Gastric ulcer;
Clinical trial phase III
- MeSH:
Endoscopy;
Humans;
Omeprazole;
Stomach Ulcer*
- From:Korean Journal of Gastrointestinal Endoscopy
2007;34(6):312-319
- CountryRepublic of Korea
- Language:Korean
-
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.
