DA-9601 for erosive gastritis: results of a double-blind placebo-controlled phase III clinical trial

• Published in: World journal of gastroenterology : WJG 2004-08, Vol.10 (16), p.2379-2382
• Main Authors: Seol, Sang-Yong, Kim, Myung-Hwan, Ryu, Jong-Sun, Choi, Myung-Gyu, Shin, Dong-Wook, Ahn, Byoung-Ok
• Format: Article
• Language: English
• Subjects: Adult; Artemisia; Clinical Research; Double-Blind Method; Female; Fibrinolytic Agents - therapeutic use; Gastritis - drug therapy; Gastritis - pathology; Humans; Male; Middle Aged; Phytotherapy - adverse effects; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Tranexamic Acid - analogs & derivatives; Tranexamic Acid - therapeutic use; Treatment Outcome
• ISSN: 1007-9327; 2219-2840
• DOI: 10.3748/wjg.v10.i16.2379

To determine the efficacy and safety of DA-9601 on erosive gastritis versus cetraxate as a standard drug by gastrointestinal endoscopy. Five hundred and twelve patients with erosive gastritis were divided into three groups. The groups received 180 mg or 360 mg of DA-9601, or 600 mg of cetraxate (Neuer) t.i.d. for 2 wk, respectively. Endoscopic observations were performed before and 2 wk after the treatment, and the cure and improvement rates were investigated. 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% vs 36%; 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 significantly higher endoscopic improvement rates than the cetraxate group in both the PP (67%, 65% vs 46%) and ITT (63%, 58% vs 45%) populations. The percentage of symptom relief 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. From these results, it appears that DA-9601 has excellent efficacy on erosive gastritis. This study also confirms the safety profile of DA-9601.