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AIM:To determine the efficacy and safety of DA-9601 onerosive gastritis versus cetraxate as a standard drug bygastrointestinal endoscopy.METHODS:Five hundred and twelve patients with erosivegastritis were divided into three groups.The groupsreceived 180 mg or 360 mg of DA-9601,or 600 mg ofcetraxate (NeuerTM) t.i.d,for 2 wk,respectively.Endoscopicobservations were performed before and 2 wk after thetreatment,and the cure and improvement rates wereinvestigated.RESULTS:Of the 512 intention-to-treat (ITT) population,457 patients comprised the per protocol (PP) analysis.Endoscopic cure rate was significantly higher in the DA-9601 group than in the cetraxate group in both the PP(56%,58% vs36%,DA-9601 180 mg,360 mg and cetraxate,respectively) and ITT (52%,51% vs 35%) populations.Two DA-9601 groups (180 and 360 mg) had significantlyhigher endoscopic improvement rates than the cetraxategroup in both the PP (67%,65% vs46%) and ITT (63%,58% vs 45%) populations.The percentage of symptomrelief over the 2 wk was found not significantly differentbetween groups.During the study,both DA-9601 andcetraxate produced no treatment-associated adverse events.CONCLUSION:From these results,it appears that DA-9601 has excellent efficacy on erosive gastritis.This studyalso confirms the safety profile of DA-9601.
AIM: To determine the efficacy and safety of DA-9601 onerosive gastritis versus cetraxate as a standard drug by gastrointestinal endoscopy. METHODS: Five hundred and twelve patients with erosivegastritis were divided into three groups. The groups were 180 mg or 360 mg of DA-9601, or 600 mg ofcetraxate (Neuer ™) tid, for 2 weeks, respectively. Endoscopic obsessions were performed before and 2 weeks after treatment, and the cure and improvement rates were investigated .RESULTS: Of the 512 intention-to-treat (ITT) population, 457 patients was significantly higher in the DA-9601 group than in cetraxate group in both the PP (56%, 58% vs 36%, DA-9601 180 mg, 360 mg and cetraxate, had significantlyhigher endoscopic improvement rates than the cetraxategroup in both the PP (67%, 65% vs46%) and ITT (52%, 51% vs 35%) populations.Two DA- (63%, 58% vs 45%) populations.The percentage of symptomrelief over the 2 wk was found not significantly different between groups. During the study, both DA-9601 and cetraxate produced no treatment-associated adverse events. CONCLUSION: From these results, it appears that DA-9601 has excellent efficacy on erosive gastritis. This studyalso confirms the safety profile of DA-9601.