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Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study

Title
Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study
Authors
Choi, Yoon JinLee, Dong HoChoi, Myung-GyuLee, Sung JoonKim, Sung KookSong, Geun AmRhee, Poong-LyulJung, Hwoon-YongKang, Dae-HwanLee, Yong ChanLee, Si HyungChoi, Suck CheiShim, Ki-NamSeol, Sang-YongMoon, Jeong SeopShin, Yong WoonKim, Hyun-SooLee, Soo TeikCho, Jin WoongChoi, Eun KwangLee, Oh YoungJang, Jin Seok
Ewha Authors
심기남
SCOPUS Author ID
심기남scopus
Issue Date
2017
Journal Title
JOURNAL OF KOREAN MEDICAL SCIENCE
ISSN
1011-8934JCR Link1598-6357JCR Link
Citation
vol. 32, no. 11, pp. 1807 - +
Keywords
ArtemisiaGastritisDouble-blind StudyAdverse Drug EventEndoscopy
Publisher
KOREAN ACAD MEDICAL SCIENCES
Indexed
SCI; SCIE; SCOPUS; KCI WOS scopus
Abstract
This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [ GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis.
DOI
10.3346/jkms.2017.32.11.1807
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의과대학 > 의학과 > Journal papers
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