Revaprazan (Revanex(R)), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial.
- Author:
In Sik CHUNG
1
;
Myung Gyu CHOI
;
Soo Heon PARK
;
Sung Kook KIM
;
Rhyn CHANG
;
Jin Hai HYUN
;
Sang Young HAN
;
Geun Am SONG
;
Chan Sup SHIM
;
Ki Baik HAHM
;
Hyun Soo KIM
;
Tae Nyeun KIM
;
Suck Chei CHOI
;
Sang Yong SEOL
;
Jong Sun REW
;
Dong Joon KIM
;
Jin LEE
;
Ho Soon CHOI
;
Geun Seog SONG
;
Byoung Seok MOON
;
Sang Aun JOO
Author Information
1. Department of Gastroenterology, The Catholic University of Korea College of Medicine, Seoul, Korea. isc@catholic.ac.kr
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Revaprazan;
Omeprazole;
Duodenal ulcer;
Phase III clinical trial
- MeSH:
Duodenal Ulcer*;
Endoscopy;
Humans;
Omeprazole;
Ulcer
- From:Korean Journal of Gastrointestinal Endoscopy
2005;31(1):17-24
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND/AIMS: To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial. METHODS: Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain. RESULTS: Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated. CONCLUSIONS: Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer.
