Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastritis / 대한소화기내시경학회지

ABSTRACT

BACKGROUND/AIMS: We performed a randomized, double-blind, phase III, multicenter trial to assess the comparative efficacy and safety of revaprazan, which is a novel acid pump antagonist in comparison with ranitidine for treating patients suffering with acute gastritis and acute aggravation of chronic gastritis. METHODS: Five hundred and twelve subjects were randomized to 2 weeks of treatment with either revaprazan 200 mg q.d. or ranitidine 150 mg b.i.d. The primary efficacy parameter was the estimated improvement rate according to endoscopy, and the secondary efficacy parameter was the improvement rate for the subjects' symptoms. RESULTS: The estimated improvement rates at 2 weeks (intention-to-treat analysis) were 79.9% with revaprazan and 60.5% with ranitidine; a significant difference was found between the two groups (p<0.0001). On the per-protocol analysis, the estimated improvement rates for revaprazan and ranitidine were 79.4% and 60.2%, respectively. There was a significant difference in the estimated improvement rates between the two groups (p<0.0001). On both analyses, there were no significant differences between the two groups for the improvement rates of the subjects' symptoms. Both drugs were well tolerated. CONCLUSIONS: The efficacy of revaprazan was higher than that of ranitidine for the estimated improvement rate according to endoscopy and also for the symptomatological improvement rate, and revaprazan was well tolerated by the subjects suffering with gastritis.