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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

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dc.contributor.author이용찬-
dc.date.accessioned2023-08-09T02:43:57Z-
dc.date.available2023-08-09T02:43:57Z-
dc.date.issued2017-11-
dc.identifier.issn1011-8934-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/195786-
dc.description.abstractThis 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 DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).-
dc.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisher대한의학회(The Korean Academy of Medical Sciences)-
dc.relation.isPartOfJOURNAL OF KOREAN MEDICAL SCIENCE-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Administration Schedule-
dc.subject.MESHFemale-
dc.subject.MESHGastric Mucosa / pathology-
dc.subject.MESHGastritis / drug therapy*-
dc.subject.MESHGastrointestinal Diseases / etiology-
dc.subject.MESHGastroscopy-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPlant Extracts / adverse effects-
dc.subject.MESHPlant Extracts / therapeutic use*-
dc.subject.MESHTreatment Outcome-
dc.titleEvaluation 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.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorYoon Jin Choi-
dc.contributor.googleauthorDong Ho Lee-
dc.contributor.googleauthorMyung Gyu Choi-
dc.contributor.googleauthorSung Joon Lee-
dc.contributor.googleauthorSung Kook Kim-
dc.contributor.googleauthorGeun Am Song-
dc.contributor.googleauthorPoong Lyul Rhee-
dc.contributor.googleauthorHwoon Yong Jung-
dc.contributor.googleauthorDae Hwan Kang-
dc.contributor.googleauthorYong Chan Lee-
dc.contributor.googleauthorSi Hyung Lee-
dc.contributor.googleauthorSuck Chei Choi-
dc.contributor.googleauthorKi Nam Shim-
dc.contributor.googleauthorSang Yong Seol-
dc.contributor.googleauthorJeong Seop Moon-
dc.contributor.googleauthorYong Woon Shin-
dc.contributor.googleauthorHyun Soo Kim-
dc.contributor.googleauthorSoo Teik Lee-
dc.contributor.googleauthorJin Woong Cho-
dc.contributor.googleauthorEun Kwang Choi-
dc.contributor.googleauthorOh Young Lee-
dc.contributor.googleauthorJin Seok Jang-
dc.identifier.doi10.3346/jkms.2017.32.11.1807-
dc.contributor.localIdA02988-
dc.contributor.localIdA03448-
dc.contributor.localIdA00127-
dc.relation.journalcodeJ01517-
dc.identifier.eissn1598-6357-
dc.identifier.pmid28960033-
dc.subject.keywordAdverse Drug Event-
dc.subject.keywordArtemisia-
dc.subject.keywordDouble-blind Study-
dc.subject.keywordEndoscopy-
dc.subject.keywordGastritis-
dc.contributor.alternativeNameLee, Yong Chan-
dc.contributor.affiliatedAuthor이용찬-
dc.citation.volume32-
dc.citation.number11-
dc.citation.startPage1807-
dc.citation.endPage1813-
dc.identifier.bibliographicCitationJOURNAL OF KOREAN MEDICAL SCIENCE, Vol.32(11) : 1807-1813, 2017-11-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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