Clinical Research
Copyright ©The Author(s) 2004. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 15, 2004; 10(16): 2379-2382
Published online Aug 15, 2004. doi: 10.3748/wjg.v10.i16.2379
DA-9601 for erosive gastritis: Results of a double-blind placebo-controlled phase III clinical trial
Sang Yong Seol, Myung Hwan Kim, Jong Sun Ryu, Myung Gyu Choi, Dong Wook Shin, Byoung Ok Ahn
Sang Yong Seol, Department of Gastroenterology, Inje University of Medicine, Busan, Korea
Myung Hwan Kim, Department of Gastroenterology, Ulsan University of Medicine, Seoul, Korea
Jong Sun Ryu, Department of Gastroenterology, Chunnam University of Medicine, Gwangju, Korea
Myung Gyu Choi, Department of Gastroenterology, Catholic University of Medicine, Seoul, Korea
Dong Wook Shin, Byoung Ok Ahn, Dong-A Pharmaceutical Research Institute, Yongin, Korea
Author contributions: All authors contributed equally to the work.
Correspondence to: Byoung Ok Ahn, Dong-A Pharmaceutical Research Institute, 47-5, Sanggal-ri, Kiheung-up, Yongin-shi, Kyunggi-do 449-905, Korea. ahnbo@donga.co.kr
Telephone: +82-31-2801394 Fax: +82-31-2828564
Received: February 6, 2004
Revised: February 14, 2004
Accepted: March 2, 2004
Published online: August 15, 2004
Abstract

AIM: To determine the efficacy and safety of DA-9601 on erosive gastritis versus cetraxate as a standard drug by gastrointestinal endoscopy.

METHODS: 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 (NeuerTM) 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.

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% 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.

CONCLUSION: From these results, it appears that DA-9601 has excellent efficacy on erosive gastritis. This study also confirms the safety profile of DA-9601.

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