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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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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

Gwang Ha Kim1 , Hang Lak Lee2 , Moon Kyung Joo3 , Hong Jun Park4 , Sung Woo Jung5 , Ok-Jae Lee6 , Hyungkil Kim7 , Hoon Jai Chun8 , Soo Teik Lee9 , Ji Won Kim10 , Han Ho Jeon11 , Il-Kwun Chung12 , Hyun-Soo Kim13 , Dong Ho Lee14 , Kyoung-Oh Kim15 , Yun Jeong Lim16 , Seun-Ja Park17 , Soo-Jeong Cho18 , Byung-Wook Kim19 , Kwang Hyun Ko20 , Seong Woo Jeon21 , Jae Gyu Kim22 , In-Kyung Sung23 , Tae Nyeun Kim24 , Jae Kyu Sung25 , and Jong-Jae Park3

1Department of Internal Medicine, Pusan National University College of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, 2Department of Internal Medicine, Hanyang University Hospital, 3Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, 4Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, 5Division of Gastroenterology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, 6Department of Internal Medicine, Gyeongsang National University College of Medicine, Jinju, 7Department of Internal Medicine, Inha University School of Medicine, Incheon, 8Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, 9Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, 10Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University of College of Medicine, Seoul, 11Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, 12Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, 13Department of Internal Medicine, Chonnam National University Hospital, Gwangju, 14Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 15Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, 16Department of Internal Medicine, Dongguk University College of Medicine, Seoul, 17Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, 18Department of Internal Medicine, Seoul National University College of Medicine, 19Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, 20Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, 21Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, 22Department of Internal Medicine, Chung-Ang University College of Medicine, 23Department of Internal Medicine, Konkuk University School of Medicine, Seoul, 24Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, and 25Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea

Correspondence to:Jong-Jae Park
ORCID https://orcid.org/0000-0002-4642-5405
E-mail gi7pjj@korea.ac.kr

Received: November 12, 2020; Revised: December 10, 2020; Accepted: December 28, 2020

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 and Liver

Published online April 7, 2021

Copyright © Gut and Liver.

Abstract

Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta (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 thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, 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-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-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-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) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Keywords: Adverse drug reaction, Gastritis, Intention-to-treat analysis, Phase III clinical trial, Rebamipide


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Gut and Liver

Published online April 7, 2021

Copyright © Gut and Liver.

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

Gwang Ha Kim1 , Hang Lak Lee2 , Moon Kyung Joo3 , Hong Jun Park4 , Sung Woo Jung5 , Ok-Jae Lee6 , Hyungkil Kim7 , Hoon Jai Chun8 , Soo Teik Lee9 , Ji Won Kim10 , Han Ho Jeon11 , Il-Kwun Chung12 , Hyun-Soo Kim13 , Dong Ho Lee14 , Kyoung-Oh Kim15 , Yun Jeong Lim16 , Seun-Ja Park17 , Soo-Jeong Cho18 , Byung-Wook Kim19 , Kwang Hyun Ko20 , Seong Woo Jeon21 , Jae Gyu Kim22 , In-Kyung Sung23 , Tae Nyeun Kim24 , Jae Kyu Sung25 , and Jong-Jae Park3

1Department of Internal Medicine, Pusan National University College of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, 2Department of Internal Medicine, Hanyang University Hospital, 3Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, 4Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, 5Division of Gastroenterology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, 6Department of Internal Medicine, Gyeongsang National University College of Medicine, Jinju, 7Department of Internal Medicine, Inha University School of Medicine, Incheon, 8Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, 9Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, 10Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University of College of Medicine, Seoul, 11Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, 12Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, 13Department of Internal Medicine, Chonnam National University Hospital, Gwangju, 14Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 15Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, 16Department of Internal Medicine, Dongguk University College of Medicine, Seoul, 17Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, 18Department of Internal Medicine, Seoul National University College of Medicine, 19Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, 20Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, 21Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, 22Department of Internal Medicine, Chung-Ang University College of Medicine, 23Department of Internal Medicine, Konkuk University School of Medicine, Seoul, 24Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, and 25Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea

Correspondence to:Jong-Jae Park
ORCID https://orcid.org/0000-0002-4642-5405
E-mail gi7pjj@korea.ac.kr

Received: November 12, 2020; Revised: December 10, 2020; Accepted: December 28, 2020

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: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta (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 thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, 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-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-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-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) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Keywords: Adverse drug reaction, Gastritis, Intention-to-treat analysis, Phase III clinical trial, Rebamipide

Gut and Liver

Vol.15 No.3
May, 2021

pISSN 1976-2283
eISSN 2005-1212

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