>   >   >   >  1996 Vol.24 no.4 (143-157)
Issue Vol.24 no.4 (143-157)
Title Late phase II study of sepimostat mesilate(FUT-187)in postgastrectomy reflux esophagitis -Clinical optimum dose in a double blind study-
Author O.Abe

 The clinical effect and optimum dose of FUT−187, a novel oral protease inhibitor, were evaluated in patients with postgastrectomy reflux esophagitis. FUT−187 was administered orally at a dose each of 100mg,200mg and 300mg/day for continuous four weeks in a double blind comparative study.

 The superior improvement of endoscopic findings and final superior over−all improvement were obtained at a dose each of 200 and 300mg/day to 100mg/day,respectively. The improvement of subjective symptoms at second week after administration,the over−all improvement of endoscopic findings and final over−all improvement were observed dose−dependently,to a significant degree.

 Adverse events were observed dose−dependently,which incidence,however,were 1.6% in the cases of 100mg/day, 9.4% in 200mg/day,and 16.1% in 300mg/day,respectively. This incidence in the case of 300mg/day were significantly higher than that in 100mg/day,and diarrhea and soft feces were recognized in the case of 300mg/day. These results suggested that the optimum dose,from the view point of safety,was 200mg/day or less.

 As a conclusion,balancing the efficacy and safety,the optimum dose of FUT−187was decided as 200mg/day.