Efficacy and Safety of Albis<SUP>Ⓡ</SUP> in Acute and Chronic Patients with Gastritis: A Double-blind, Placebo-controlled, Randomized Multi-center Study

Korean J Gastrointest Endosc > Volume 42(4); 2011 > Article

Korean Journal of Gastrointestinal Endoscopy 2011;42(4): 215-221.

미란성 위염에 대한 알비스^Ⓡ의 효과: 스티렌^Ⓡ 대조 무작위 이중맹검 다기관 임상시험

한혜원ㆍ최명규ㆍ설상영*ㆍ이동호^†ㆍ정훈용^‡ㆍ김태년^§ㆍ최석채^∥ㆍ김현수^¶

가톨릭대학교 의과대학 내과학교실, *인제대학교 의과대학 부산백병원 내과학교실, ^†서울대학교 의과대학 내과학교실, ^‡울산대학교 의과대학 내과학교실, ^§영남대학교 의과대학 내과학교실, ^∥원광대학교 의과대학 내과학교실, ^¶전남대학교 의과대학 내과학교실

Efficacy and Safety of Albis^Ⓡ in Acute and Chronic Patients with Gastritis: A Double-blind, Placebo-controlled, Randomized Multi-center Study

Hae Won Han, M.D., Myung-Gyu Choi, M.D., Sang Young Seol, M.D.*, Dong Ho Lee, M.D.^†, Hwoon-Yong Jung, M.D.^‡, Tae Nyeun Kim, M.D.^§, Suck Chei Choi, M.D.^∥ and Hyen Soo Kim, M.D.^¶

Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, *Pusan Paik Hospital, Inje University College of Medicine, Busan, ^†Seoul National University College of Medicine, ^‡University of Ulsan College of Medicine, Seoul, ^§Yeungnam University College of Medicine, Daegu, ^∥Wonkwang University College of Medicine, Iksan, ^¶Chonnam National University Medical School, Gwangju, Korea

Abstract

Background/Aims:
Albis^Ⱂ is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to prove non-inferiority of Albis^Ⱂ compared to Stillen^Ⱂ for treating erosive gastritis.
Methods:
This study was a randomized, double-blind, multi-center trial. The primary endpoint was 2 weeks of treatment.
Results:
Of the 229 patients in the intention-to-treat (ITT) population, 87 from the Albis^Ⱂ, and 96 from the Stillen^Ⱂ group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis^Ⱂ group and the control in both the PP (42.5%, 39.6%) and ITT (35.3%, 34.5%) populations. The endoscopic cure of erosion was also not different in the Albis^Ⱂ group than that in the control group in both the PP (32.3%, 31.3%) and ITT (27.6%, 27.4%) populations. The endoscopic improvement rate for hemorrhage, edema, and erythema were also not different between the two groups in both the PP and ITT populations. No statistically significant differences were observed for adverse events between the two groups.
Conclusions:
Half of the approved dose of Albis^Ⱂ for peptic ulcers has non-inferiority compared to Stillen^Ⱂ for treating erosive gastritis. A low dosage of Albis^Ⱂ is cost efficient and safe. (Korean J Gastrointest Endosc 2011;42:215-221)

Key Words: Albis^Ⱂ, Stillen^Ⱂ, Erosive gastritis, Clinical trial

주요어: 알비스^Ⱂ, 스티렌^Ⱂ, 미란성 위염, 임상 시험