Effect of p-hydroxyphenyl-propionic ester of tranexamic acid hydrochloride (Cetraxate) on peptic ulcer. Multi-center clinical study.

Abstract

The therapeutic effects of a new antiulcer drug, a p-hydroxyphenyl-propionic ester of tranexamic acid (cetraxate, CET) hydrochloride, were investigated in 234 patients with gastric ulcer by double blind controlled study using trans-3,7-dimethyl-2,6-octadienyl-5,9,13-trimethyltetradeca-4,8,12-trienoate (gefarnate) as the standard drug in 18 medical institutions. The cure rates confirmed by endoscopic examination in CET-treated patients were 28, 61 and 73% each after 4, 8 and 12 weeks of medication, while those in gefarnate-treated patients were 23, 47 and 55%, respectively, with statistical significance after 8 and 12 weeks. Global utility rate based on the judgement by the physician in charge also supported the results with cure rate. Stratified analysis again confirmed the superiority of CET hydrochloride against gefarnate in the hospitalized patients in terms of both cure rate and global utility rate. However, there was no significant difference between the two drugs as to the effects in the out-patients. Among the symptoms, there was also a significant difference between the improvement rate of epigastralgia with the two drugs in favour of CET hydrochloride. No serious side effects were reported throughout the study.