Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study
Background/Aims : Clinical data on the efficacy and safety of the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited. Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions. Methods : In t...
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Gastroenterology Council for Gut and Liver
2025-07-01
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| Series: | Gut and Liver |
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| Online Access: | http://gutnliver.org/journal/view.html?doi=10.5009/gnl240390 |
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| author | Hyun Lim Ju Yup Lee Yong Hwan Kwon Hee Seok Moon Jong Kyu Park Ki Bae Kim Sang Wook Kim Young Hoon Youn Sang Gyun Kim Gwang Ha Kim Ji Won Kim Jae-Young Jang Kye Sook Kwon Joong Goo Kwon Hyun-Soo Kim Su Jin Hong Kwang Jae Lee Suck Chei Choi Jeong Seop Moon Nayoung Kim Jong-Jae Park Yirang Lim Sung Hee Hong Hwoon-Yong Jung |
| author_facet | Hyun Lim Ju Yup Lee Yong Hwan Kwon Hee Seok Moon Jong Kyu Park Ki Bae Kim Sang Wook Kim Young Hoon Youn Sang Gyun Kim Gwang Ha Kim Ji Won Kim Jae-Young Jang Kye Sook Kwon Joong Goo Kwon Hyun-Soo Kim Su Jin Hong Kwang Jae Lee Suck Chei Choi Jeong Seop Moon Nayoung Kim Jong-Jae Park Yirang Lim Sung Hee Hong Hwoon-Yong Jung |
| author_sort | Hyun Lim |
| collection | DOAJ |
| description | Background/Aims : Clinical data on the efficacy and safety of the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited. Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions. Methods : In this multicenter, randomized, double-blind, active-control, phase III study, 326 patients with endoscopically proven gastric mucosal erosion were randomly assigned to receive either HIP2101 or RLD2101 once daily for 2 weeks. The primary endpoint was the rate of improvement of erosion. Secondary endpoints (rate of cure of erosion and edema, and rate of improvement of hematin and gastrointestinal symptoms) and treatment-emergent adverse events were compared between the groups. Results : Based on the per-protocol set (PPS) analysis, the improvement rates for erosion were 64.9% (98/151) and 63.7% (100/157) in the HIP2101 and RLD2101 groups, respectively (95% confidence interval, –9.5 to 11.9). The lower bound of the 95% confidence interval was greater than the noninferiority margin of –14%. These results were similar to those of the full analysis set (FAS) (HIP2101 group, 64.6%; RLD2101 group, 62.7%). Based on the PPS and FAS analyses, the cure rates for erosion and edema and the improvement rates for hematin and gastrointestinal symptoms were comparable between the groups. The number of adverse events did not differ significantly between the groups. Conclusions : The efficacy and safety of HIP2101 were comparable to those of RLD2101 in the treatment of gastric erosions and symptomatic improvement. These findings suggest that HIP2101 may be a novel treatment option for gastritis (ClinicalTrials.gov identifier: NCT05024721). |
| format | Article |
| id | doaj-art-56d2da35d600414481fd70dc6e4d0519 |
| institution | DOAJ |
| issn | 1976-2283 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Gastroenterology Council for Gut and Liver |
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| series | Gut and Liver |
| spelling | doaj-art-56d2da35d600414481fd70dc6e4d05192025-08-20T03:11:49ZengGastroenterology Council for Gut and LiverGut and Liver1976-22832025-07-0119451952710.5009/gnl240390gnl240390Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III StudyHyun Lim0Ju Yup Lee1Yong Hwan Kwon2Hee Seok Moon3Jong Kyu Park4Ki Bae Kim5Sang Wook Kim6Young Hoon Youn7Sang Gyun Kim8Gwang Ha Kim9Ji Won Kim10Jae-Young Jang11Kye Sook Kwon12Joong Goo Kwon13Hyun-Soo Kim14Su Jin Hong15Kwang Jae Lee16Suck Chei Choi17Jeong Seop Moon18Nayoung Kim19Jong-Jae Park20Yirang Lim21Sung Hee Hong22Hwoon-Yong Jung23Department of Internal Medicine, Hallym University College of Medicine, University of Hallym College of Medicine, Anyang, KoreaDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, KoreaDepartment of Internal Medicine, Kyungpook National University Hospital, Daegu, KoreaDepartment of Internal Medicine, Chungnam National University College of Medicine, Daejeon, KoreaDepartment of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, KoreaDepartment of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, KoreaDepartment of Internal Medicine, Jeonbuk National University Hospital, Jeonju, KoreaDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, KoreaDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, KoreaDepartment of Internal Medicine, Pusan National University School of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, KoreaDepartment of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, KoreaDepartment of Gastroenterology and Hepatology, College of Medicine, Kyung Hee University, Seoul, KoreaDivision of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, Incheon, KoreaDepartment of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, KoreaDepartment of Internal Medicine, Chonnam National University Hospital, Gwangju, KoreaDigestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, KoreaDepartment of Gastroenterology, Ajou University School of Medicine, Suwon, KoreaDepartment of Gastroenterology, Digestive Disease Research Institute, Wonkwang University Hospital, Iksan, KoreaDepartment of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, KoreaDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, KoreaDivision of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, KoreaHanmi Pharmaceutical Co., Ltd., Seoul, KoreaHanmi Pharmaceutical Co., Ltd., Seoul, KoreaDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaBackground/Aims : Clinical data on the efficacy and safety of the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited. Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions. Methods : In this multicenter, randomized, double-blind, active-control, phase III study, 326 patients with endoscopically proven gastric mucosal erosion were randomly assigned to receive either HIP2101 or RLD2101 once daily for 2 weeks. The primary endpoint was the rate of improvement of erosion. Secondary endpoints (rate of cure of erosion and edema, and rate of improvement of hematin and gastrointestinal symptoms) and treatment-emergent adverse events were compared between the groups. Results : Based on the per-protocol set (PPS) analysis, the improvement rates for erosion were 64.9% (98/151) and 63.7% (100/157) in the HIP2101 and RLD2101 groups, respectively (95% confidence interval, –9.5 to 11.9). The lower bound of the 95% confidence interval was greater than the noninferiority margin of –14%. These results were similar to those of the full analysis set (FAS) (HIP2101 group, 64.6%; RLD2101 group, 62.7%). Based on the PPS and FAS analyses, the cure rates for erosion and edema and the improvement rates for hematin and gastrointestinal symptoms were comparable between the groups. The number of adverse events did not differ significantly between the groups. Conclusions : The efficacy and safety of HIP2101 were comparable to those of RLD2101 in the treatment of gastric erosions and symptomatic improvement. These findings suggest that HIP2101 may be a novel treatment option for gastritis (ClinicalTrials.gov identifier: NCT05024721).http://gutnliver.org/journal/view.html?doi=10.5009/gnl240390proton pump inhibitors; hip2101; esomeprazole; gastritis; rld2101 |
| spellingShingle | Hyun Lim Ju Yup Lee Yong Hwan Kwon Hee Seok Moon Jong Kyu Park Ki Bae Kim Sang Wook Kim Young Hoon Youn Sang Gyun Kim Gwang Ha Kim Ji Won Kim Jae-Young Jang Kye Sook Kwon Joong Goo Kwon Hyun-Soo Kim Su Jin Hong Kwang Jae Lee Suck Chei Choi Jeong Seop Moon Nayoung Kim Jong-Jae Park Yirang Lim Sung Hee Hong Hwoon-Yong Jung Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study Gut and Liver proton pump inhibitors; hip2101; esomeprazole; gastritis; rld2101 |
| title | Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study |
| title_full | Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study |
| title_fullStr | Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study |
| title_full_unstemmed | Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study |
| title_short | Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study |
| title_sort | evaluation of the efficacy and safety of a dual delayed release formulation of 10 mg esomeprazole in patients with gastric erosions a multicenter randomized double blind active control phase iii study |
| topic | proton pump inhibitors; hip2101; esomeprazole; gastritis; rld2101 |
| url | http://gutnliver.org/journal/view.html?doi=10.5009/gnl240390 |
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