|
KMID : 0359020070340060312
|
|
Korean Journal of Gastrointestinal Endoscopy
2007 Volume.34 No. 6 p.312 ~ p.319
|
|
|
Phase III Clinical Trial of Revaprazan (Revanex) for Gastric Ulcer
|
|
Chang Rin
Song Geun-Am
Rew Jong-Sun
Choi Ho-Soon
Chung In-Sik
Seol Sang-Yong
Lee Jin
Kim Hyun-Soo
Kim Sung-Kook
Choi Seok-Reyol
Kim Dong-Joon
Hahm Ki-Baik
Kim Tae-Nyeun
Park Soo-Heon
Choi Suck-Chei
Lee Yong-Chan
Lee Jung-Eun
Song Geun-Seog
Moon Byung-Seok
Joo Sang-Aun
|
|
|
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.
|
|
|
KEYWORD
|
|
|
Revaprazan, Omeprazole, Gastric ulcer, Clinical trial phase III
|
|
|
FullTexts / Linksout information
|
|
|
|
|
Listed journal information
|
|
  
|