A Phase III Clinical Trial of Stillen(TM) for Erosive Gastritis / 대한소화기내시경학회지

ABSTRACT

BACKGROUND/AIMS: Phase IIb clinical study of Stillen(TM), a novel cytoprotectant, for gastritis showed 180 mg of Stillen, t.i.d. for 2 weeks results in a significant increase of cure rate when compared with a placebo group. It is reported that antioxidative effect and strengthening the endogenous cytoprotective molecules of the gastric mucosa play a pivotal role for cytoprotective action of Stillen(TM). The aim of this phase III multicenter, double-blind comparative study was to assess the efficacy of Stillen(TM) for the treatment of erosive gastritis. METHODS: Five hundred and twelve patients with erosive gastritis were enrolled and divided into three groups. Each group received 180 mg or 360 mg of Stillen(TM) or 600 mg of cetraxate (Neuer(TM)) t.i.d. for 2 weeks, respectively and a follow-up endoscopic examination for evaluation. RESULTS: Patients treated with 180 mg and 360 mg of Stillen(TM) had a significantly improved endoscopic cure rate of gastritis (55.6% and 57.5%, respectively) compared with patients treated with 600 mg of cetraxate (35.5%, p<0.001). Endoscopic improvement rate was also significantly higher in 180 mg group (67.3%) and 360 mg group (65.0%) of Stillen(TM) treated patients than cetraxate treated group (46.4%, p<0.001). During the study, both Stillen(TM) and cetraxate were well tolerated. CONCLUSIONS: These results clearly demonstrate that Stillen(TM) is an efficacious, safe, and well-tolerated treatment for gastritis.