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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
DC Field | Value | Language |
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dc.contributor.author | 이용찬 | - |
dc.date.accessioned | 2023-08-09T02:43:57Z | - |
dc.date.available | 2023-08-09T02:43:57Z | - |
dc.date.issued | 2017-11 | - |
dc.identifier.issn | 1011-8934 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195786 | - |
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 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.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | 대한의학회(The Korean Academy of Medical Sciences) | - |
dc.relation.isPartOf | JOURNAL OF KOREAN MEDICAL SCIENCE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Gastric Mucosa / pathology | - |
dc.subject.MESH | Gastritis / drug therapy* | - |
dc.subject.MESH | Gastrointestinal Diseases / etiology | - |
dc.subject.MESH | Gastroscopy | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Plant Extracts / adverse effects | - |
dc.subject.MESH | Plant Extracts / therapeutic use* | - |
dc.subject.MESH | Treatment Outcome | - |
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.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Yoon Jin Choi | - |
dc.contributor.googleauthor | Dong Ho Lee | - |
dc.contributor.googleauthor | Myung Gyu Choi | - |
dc.contributor.googleauthor | Sung Joon Lee | - |
dc.contributor.googleauthor | Sung Kook Kim | - |
dc.contributor.googleauthor | Geun Am Song | - |
dc.contributor.googleauthor | Poong Lyul Rhee | - |
dc.contributor.googleauthor | Hwoon Yong Jung | - |
dc.contributor.googleauthor | Dae Hwan Kang | - |
dc.contributor.googleauthor | Yong Chan Lee | - |
dc.contributor.googleauthor | Si Hyung Lee | - |
dc.contributor.googleauthor | Suck Chei Choi | - |
dc.contributor.googleauthor | Ki Nam Shim | - |
dc.contributor.googleauthor | Sang Yong Seol | - |
dc.contributor.googleauthor | Jeong Seop Moon | - |
dc.contributor.googleauthor | Yong Woon Shin | - |
dc.contributor.googleauthor | Hyun Soo Kim | - |
dc.contributor.googleauthor | Soo Teik Lee | - |
dc.contributor.googleauthor | Jin Woong Cho | - |
dc.contributor.googleauthor | Eun Kwang Choi | - |
dc.contributor.googleauthor | Oh Young Lee | - |
dc.contributor.googleauthor | Jin Seok Jang | - |
dc.identifier.doi | 10.3346/jkms.2017.32.11.1807 | - |
dc.contributor.localId | A02988 | - |
dc.contributor.localId | A03448 | - |
dc.contributor.localId | A00127 | - |
dc.relation.journalcode | J01517 | - |
dc.identifier.eissn | 1598-6357 | - |
dc.identifier.pmid | 28960033 | - |
dc.subject.keyword | Adverse Drug Event | - |
dc.subject.keyword | Artemisia | - |
dc.subject.keyword | Double-blind Study | - |
dc.subject.keyword | Endoscopy | - |
dc.subject.keyword | Gastritis | - |
dc.contributor.alternativeName | Lee, Yong Chan | - |
dc.contributor.affiliatedAuthor | 이용찬 | - |
dc.citation.volume | 32 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1807 | - |
dc.citation.endPage | 1813 | - |
dc.identifier.bibliographicCitation | JOURNAL OF KOREAN MEDICAL SCIENCE, Vol.32(11) : 1807-1813, 2017-11 | - |
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