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HOME > Clin Endosc > Volume 42(4); 2011 > Article
Efficacy and Safety of Albis in Acute and Chronic Patients with Gastritis: A Double-blind, Placebo-controlled, Randomized Multi-center Study
Clinical Endoscopy 2011;42(4):215-221.
DOI: https://doi.org/
Published online: April 28, 2011
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
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Background
/Aims: Albis is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to prove non-inferiority of Albis compared to Stillen 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, and 96 from the Stillen group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis 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 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 for peptic ulcers has non-inferiority compared to Stillen for treating erosive gastritis. A low dosage of Albis is cost efficient and safe. (Korean J Gastrointest Endosc 2011;42:215-221)


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