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  • 1. Aims and Scope

    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Editor-in-Chief
    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

    Deputy Editor

    Deputy Editor
    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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    All papers submitted to Gut and Liver are reviewed by the editorial team before being sent out for an external peer review to rule out papers that have low priority, insufficient originality, scientific flaws, or the absence of a message of importance to the readers of the Journal. A decision about these papers will usually be made within two or three weeks.
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A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease

Su Hyun Park1 , Kang Nyeong Lee1 , Oh Young Lee1 , Myung Gyu Choi2 , Jie-Hyun Kim3 , In-Kyung Sung4 , Jae Young Jang5 , Kyung Sik Park6 , Hoon Jai Chun7 , Eun Young Kim8 , Jun Kyu Lee9 , Jin Seok Jang10 , Gwang Ha Kim11 , Su Jin Hong12 , Yong Chan Lee13 , Suck-Chei Choi14 , Hyun Soo Kim15 , Tae Oh Kim16 , Gwang Ho Baik17 , and Yong Cheol Jeon18

1Department of Internal Medicine, Hanyang University College of Medicine, 2Department of Internal Medicine, College of Medicine, The Catholic University of Korea, 3Department of Internal Medicine, Gangnam Severance Hospital, 4Department of Internal Medicine, Konkuk University College of Medicine, 5Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul, 6Department of Internal Medicine, Keimyung University College of Medicine, Daegu, 7Department of Internal Medicine, Korea University Anam Hospital, Seoul, 8Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, 9Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, 10Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, 11Department of Internal Medicine, Pusan National University School of Medicine, Busan, 12Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, 13Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, 14Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, 15Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 16Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, 17Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, and 18Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea

Correspondence to:Oh Young Lee
ORCID https://orcid.org/0000-0002-6025-530X
E-mail leeoy@hanyang.ac.kr

Su Hyun Park and Kang Nyeong Lee equally contributed to the study as first authors.

Received: January 18, 2022; Revised: March 19, 2022; Accepted: April 1, 2022

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut Liver

Published online June 22, 2022

Copyright © Gut and Liver.

Abstract

Background/Aims: Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods: This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either Esoduo (esomeprazole 20 mg with sodium bicarbonate 800 mg) or Nexium (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results: A total of 355 patients completed the study (180 in the Esoduo group and 175 in the Nexium group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the Esoduo group and 35% in the Nexium group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions: Esoduo is as effective and safe as Nexium for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Keywords: Gastroesophageal reflux, Phase IV clinical trial, Esomeprazole, Sodium bicarbonate


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Gut and Liver

Published online June 22, 2022

Copyright © Gut and Liver.

A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease

Su Hyun Park1 , Kang Nyeong Lee1 , Oh Young Lee1 , Myung Gyu Choi2 , Jie-Hyun Kim3 , In-Kyung Sung4 , Jae Young Jang5 , Kyung Sik Park6 , Hoon Jai Chun7 , Eun Young Kim8 , Jun Kyu Lee9 , Jin Seok Jang10 , Gwang Ha Kim11 , Su Jin Hong12 , Yong Chan Lee13 , Suck-Chei Choi14 , Hyun Soo Kim15 , Tae Oh Kim16 , Gwang Ho Baik17 , and Yong Cheol Jeon18

1Department of Internal Medicine, Hanyang University College of Medicine, 2Department of Internal Medicine, College of Medicine, The Catholic University of Korea, 3Department of Internal Medicine, Gangnam Severance Hospital, 4Department of Internal Medicine, Konkuk University College of Medicine, 5Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul, 6Department of Internal Medicine, Keimyung University College of Medicine, Daegu, 7Department of Internal Medicine, Korea University Anam Hospital, Seoul, 8Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, 9Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, 10Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, 11Department of Internal Medicine, Pusan National University School of Medicine, Busan, 12Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, 13Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, 14Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, 15Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 16Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, 17Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, and 18Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea

Correspondence to:Oh Young Lee
ORCID https://orcid.org/0000-0002-6025-530X
E-mail leeoy@hanyang.ac.kr

Su Hyun Park and Kang Nyeong Lee equally contributed to the study as first authors.

Received: January 18, 2022; Revised: March 19, 2022; Accepted: April 1, 2022

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims: Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods: This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either Esoduo (esomeprazole 20 mg with sodium bicarbonate 800 mg) or Nexium (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results: A total of 355 patients completed the study (180 in the Esoduo group and 175 in the Nexium group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the Esoduo group and 35% in the Nexium group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions: Esoduo is as effective and safe as Nexium for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Keywords: Gastroesophageal reflux, Phase IV clinical trial, Esomeprazole, Sodium bicarbonate

Gut and Liver

Vol.16 No.3
May, 2022

pISSN 1976-2283
eISSN 2005-1212

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