Evidence map›Paper›PMID 39587796›Full record

Trial reportNeurogastroenterology and motility2025

Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi-Center, Randomized, Double-Blind, Active-Comparator Phase 4 Trial.

Cheol Min Shin, Suck Chei Choi, Jin Woong Cho, Seung Young Kim, Ok Jae Lee, Do Hoon Kim, Yu Kyung Cho, Ju Yup Lee, Sang Kil Lee, Jeong Eun Shin and 10 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurogastroenterology and motility, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05267743 (A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05267743 phase4completednot on this map

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease

TypeinterventionalSponsorHK inno.N CorporationRan2021 to 2022Enrolled218ConditionsErosive Reflux DiseaseArmsTegoprazan 50mg QD, Lansoprazole 30mg QD
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Cheol Min ShinDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.ORCID https://orcid.org/0000-0003-2265-9845
Suck Chei ChoiDepartment of Gastroenterology, School of Medicine, Wonkwang University, Iksan, Korea.ORCID https://orcid.org/0000-0003-1338-3306
Jin Woong ChoDepartment of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea.
Seung Young KimDepartment of Gastroenterology, Korea University Ansan Hospital, Ansan, Korea.
Ok Jae LeeDepartment of Internal Medicine, Gyeongsang National University Hospital, Jinju, Korea.
Do Hoon KimDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Yu Kyung ChoDepartment of Internal Medicine, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-7297-6577
Ju Yup LeeDepartment of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea.
Sang Kil LeeDepartment of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Jeong Eun ShinDepartment of Gastroenterology, Dankook University Hospital, Cheonan, Korea.
Gwang Ha KimDepartment of Internal Medicine, Pusan National University College of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.
Seon-Young ParkDepartment of Gastroenterology, Chonnam National University Hospital, Gwangju, Korea.ORCID https://orcid.org/0000-0002-0962-5977
Su Jin HongDepartment of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
Hye-Kyung JungDepartment of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Korea.ORCID https://orcid.org/0000-0002-6653-5214
Sang Jin LeeDepartment of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
Young Hoon YounDepartment of Gastroenterology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-0071-229X
Seong Woo JeonDepartment of Gastroenterology, Kyungpook National University Chilgok Hospital, Daegu, Korea.
In Kyung SungDepartment of Internal Medicine, Konkuk University Medical Center, Seoul, Korea.
Moo In ParkDepartment of Gastroenterology, Kosin University Gospel Hospital, Busan, Korea.
Oh Young LeeDepartment of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.

Funding

This study was funded in full by HK inno.N Corp., Seoul, Korea.
6 · The paper itself

Abstract

backgroundThe aims of this study were to confirm the non-inferiority of tegoprazan to lansoprazole up to week 4 in patients with erosive esophagitis (EE) and to evaluate its effectiveness in rapid mucosal healing and symptom relief at week 2.

methodsIn this multi-center, randomized, double-blind, active-comparator non-inferiority trial, 218 patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either the tegoprazan (50 mg) or lansoprazole (30 mg) group. The primary endpoint was the cumulative proportion of patients with healed EE up to week 4, as confirmed through endoscopy. The proportion of patients with healed EE at week 2 was also evaluated. Furthermore, CYP2C19 genotypes, symptoms, safety, and tolerability were assessed. KEY

resultsIn the full-analysis set, 103 and 109 participants in the tegoprazan and lansoprazole groups, respectively, were analyzed. The cumulative healing rates up to week 4 were 95.2% (98/103) and 86.2% (94/109) (difference [95% confidence interval], 8.91 [1.22-16.59]; p < 0.0001 for non-inferiority and 0.0266 for superiority), while those at week 2 were 88.4% (91/103) and 82.6% (90/109) (5.78 [-3.66-15.22], p = 0.0005 for non-inferiority) for tegoprazan and lansoprazole, respectively. Tegoprazan showed consistent healing rates regardless of CYP2C19 genotypes. CONCLUSIONS AND INFERENCES: Tegoprazan was superior to lansoprazole in the treatment of EE up to 4 weeks. Further studies are necessary to confirm these findings and clarify the superiority of tegoprazan, especially in the treatment of severe EE.

trial registrationClinicalTrials.gov identifier: NCT05267743.

Indexed as

LansoprazoleProton Pump InhibitorsAdultAgedCytochrome P-450 CYP2C19Double-Blind MethodEsophagitisFemaleHumansMaleMiddle AgedTreatment OutcomeCYP2C19 protein, humanCytochrome P-450 CYP2C19LansoprazoleProton Pump Inhibitorserosive esophagitislansoprazolepotassium competitive acid blockerproton pump inhibitortegoprazan

Identifiers

PMID39587796
PMCPMC11650551

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.