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

ABSTRACT

BACKGROUND/AIMS: Albis(R) is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to demonstrate the efficacy and safety superiority of Albis(R) compared to Stillen(R) 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(R), and 96 from the Stillen(R) group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis(R)(R) 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(R) 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(R) for peptic ulcers was superior to Stillen(R). A low dosage of Albis(R) is more cost efficient and safe than that of Stillen(R).