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
DC Field | Value | Language |
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dc.contributor.author | Choi, Yoon Jin | - |
dc.contributor.author | Lee, Dong Ho | - |
dc.contributor.author | Choi, Myung-Gyu | - |
dc.contributor.author | Lee, Sung Joon | - |
dc.contributor.author | Kim, Sung Kook | - |
dc.contributor.author | Song, Geun Am | - |
dc.contributor.author | Rhee, Poong-Lyul | - |
dc.contributor.author | Jung, Hwoon-Yong | - |
dc.contributor.author | Kang, Dae-Hwan | - |
dc.contributor.author | Lee, Yong Chan | - |
dc.contributor.author | Lee, Si Hyung | - |
dc.contributor.author | Choi, Suck Chei | - |
dc.contributor.author | Shim, Ki-Nam | - |
dc.contributor.author | Seol, Sang-Yong | - |
dc.contributor.author | Moon, Jeong Seop | - |
dc.contributor.author | Shin, Yong Woon | - |
dc.contributor.author | Kim, Hyun-Soo | - |
dc.contributor.author | Lee, Soo Teik | - |
dc.contributor.author | Cho, Jin Woong | - |
dc.contributor.author | Choi, Eun Kwang | - |
dc.contributor.author | Lee, Oh Young | - |
dc.contributor.author | Jang, Jin Seok | - |
dc.date.accessioned | 2021-07-30T05:17:23Z | - |
dc.date.available | 2021-07-30T05:17:23Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2017-11 | - |
dc.identifier.issn | 1011-8934 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/4005 | - |
dc.description.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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | KOREAN ACAD MEDICAL SCIENCES | - |
dc.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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, Oh Young | - |
dc.identifier.doi | 10.3346/jkms.2017.32.11.1807 | - |
dc.identifier.scopusid | 2-s2.0-85030182288 | - |
dc.identifier.wosid | 000416688800014 | - |
dc.identifier.bibliographicCitation | JOURNAL OF KOREAN MEDICAL SCIENCE, v.32, no.11, pp.1807 - 1813 | - |
dc.relation.isPartOf | JOURNAL OF KOREAN MEDICAL SCIENCE | - |
dc.citation.title | JOURNAL OF KOREAN MEDICAL SCIENCE | - |
dc.citation.volume | 32 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1807 | - |
dc.citation.endPage | 1813 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002278785 | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | General & Internal Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, General & Internal | - |
dc.subject.keywordPlus | ARTEMISIA-ASIATICA | - |
dc.subject.keywordPlus | EPITHELIAL-CELLS | - |
dc.subject.keywordPlus | IN-VITRO | - |
dc.subject.keywordPlus | EXTRACT | - |
dc.subject.keywordPlus | TABLET | - |
dc.subject.keywordPlus | DAMAGE | - |
dc.subject.keywordPlus | RATS | - |
dc.subject.keywordAuthor | Artemisia | - |
dc.subject.keywordAuthor | Gastritis | - |
dc.subject.keywordAuthor | Double-blind Study | - |
dc.subject.keywordAuthor | Adverse Drug Event | - |
dc.subject.keywordAuthor | Endoscopy | - |
dc.identifier.url | https://jkms.org/DOIx.php?id=10.3346/jkms.2017.32.11.1807 | - |
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