Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study
DC Field | Value | Language |
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dc.contributor.author | Kim, Gwang Ha | - |
dc.contributor.author | Lee, Hang Lak | - |
dc.contributor.author | Joo, Moon Kyung | - |
dc.contributor.author | Park, Hong Jun | - |
dc.contributor.author | Jung, Sung Woo | - |
dc.contributor.author | Lee, Ok-Jae | - |
dc.contributor.author | Kim, Hyungkil | - |
dc.contributor.author | Chun, Hoon Jai | - |
dc.contributor.author | Lee, Soo Teik | - |
dc.contributor.author | Kim, Ji Won | - |
dc.contributor.author | Jeon, Han Ho | - |
dc.contributor.author | Chung, Il-Kwun | - |
dc.contributor.author | Kim, Hyun-Soo | - |
dc.contributor.author | Lee, Dong Ho | - |
dc.contributor.author | Kim, Kyoung-Oh | - |
dc.contributor.author | Lim, Yun Jeong | - |
dc.contributor.author | Park, Seun-Ja | - |
dc.contributor.author | Cho, Soo-Jeong | - |
dc.contributor.author | Kim, Byung-Wook | - |
dc.contributor.author | Ko, Kwang Hyun | - |
dc.contributor.author | Jeon, Seong Woo | - |
dc.contributor.author | Kim, Jae Gyu | - |
dc.contributor.author | Sung, In-Kyung | - |
dc.contributor.author | Kim, Tae Nyeun | - |
dc.contributor.author | Sung, Jae Kyu | - |
dc.contributor.author | Park, Jong-Jae | - |
dc.date.accessioned | 2021-10-18T07:40:16Z | - |
dc.date.available | 2021-10-18T07:40:16Z | - |
dc.date.issued | 2021-11 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.issn | 2005-1212 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/50347 | - |
dc.description.abstract | Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta (R) (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta (R) thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta (R), n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta (R), n=215). The posttreatment assessments included the primary (erosion im-provement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of red-ness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta (R)-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta (R)- treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was -4.01% (95% confidence interval [CI], -13.09% to 5.06%) in the ITT analysis and -4.44% (95% CI, -13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta (R)-treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta (R)) thrice daily. Both formulations showed a similar efficacy in treat-ing erosive gastritis. (Gut Liver, Published online April 7, 2021) | - |
dc.format.extent | 10 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | EDITORIAL OFFICE GUT & LIVER | - |
dc.title | Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study | - |
dc.type | Article | - |
dc.identifier.doi | 10.5009/gnl20338 | - |
dc.identifier.bibliographicCitation | GUT AND LIVER, v.15, no.6, pp 841 - 850 | - |
dc.identifier.kciid | ART002776033 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.wosid | 000703342700001 | - |
dc.identifier.scopusid | 2-s2.0-85119337237 | - |
dc.citation.endPage | 850 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 841 | - |
dc.citation.title | GUT AND LIVER | - |
dc.citation.volume | 15 | - |
dc.type.docType | Article | - |
dc.publisher.location | 대한민국 | - |
dc.subject.keywordAuthor | Adverse drug reaction | - |
dc.subject.keywordAuthor | Gastritis | - |
dc.subject.keywordAuthor | Intention-to-treat analysis | - |
dc.subject.keywordAuthor | Phase III clinical trial | - |
dc.subject.keywordAuthor | Rebamipide | - |
dc.subject.keywordPlus | HELICOBACTER-PYLORI | - |
dc.subject.keywordPlus | MECHANISMS | - |
dc.subject.keywordPlus | DA-9601 | - |
dc.subject.keywordPlus | RISK | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
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