Evidence map›Paper›PMID 42325011›Full record

Trial reportGut and liver2026

A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs.

Sang Gyun Kim, Tae-Oh Kim, Sung Woo Jung, Byung-Hoon Min, Jung-Hwan Oh, Hyun-Soo Kim, Gil Ho Lee, Ji Hyun Song, In Kyung Sung, Young Sin Cho and 25 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Gut and liver, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04840550 (A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04840550 phase3unknown statusnot on this map

A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs

TypeinterventionalSponsorHK inno.N CorporationRan2021 to 2024Enrolled390ConditionsPreventive Peptic UlcerArmsLansoprazole 15 mg, Tegoprazan 25 mg
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

35 authors.

Sang Gyun KimDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.ORCID 0000-0003-1799-9028
Tae-Oh KimDepartment of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.ORCID 0000-0002-7359-1599
Sung Woo JungDepartment of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.ORCID 0000-0003-1954-1678
Byung-Hoon MinDepartment of Medicine, Samsung Medical Center, Seoul, Korea.ORCID 0000-0001-8048-361X
Jung-Hwan OhDepartment of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0002-9274-882X
Hyun-Soo KimDepartment of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea.ORCID 0000-0001-7190-0362
Gil Ho LeeDepartment of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.ORCID 0000-0001-7695-0828
Ji Hyun SongDepartment of Internal Medicine, Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Korea.ORCID 0000-0001-9459-9250
In Kyung SungDepartment of Internal Medicine, Konkuk University Medical Center, Seoul, Korea.ORCID 0000-0002-3848-5571
Young Sin ChoDepartment of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.ORCID 0000-0001-7090-2921
Suck Chei ChoiDepartment of Internal Medicine, Wonkwang University Hospital, Iksan, Korea.ORCID 0000-0003-1338-3306
Yun Jeong LimDepartment of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea.ORCID 0000-0002-3279-332X
Byung-Wook KimDepartment of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.ORCID 0000-0002-2290-4954
Cheol Min ShinDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.ORCID 0000-0003-2265-9845
Cheal Wung HuhDepartment of Internal Medicine, Yongin Severance Hospital, Yongin, Korea.ORCID 0000-0001-7327-8503
Ji Won KimDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.ORCID 0000-0002-1214-5544
Kyung-Oh KimDepartment of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.ORCID 0000-0002-5365-2550
Yu Kyung ChoDepartment of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID 0000-0002-7297-6577
Oh Young LeeDepartment of Internal Medicine, Hanyang University Hospital, Seoul, Korea.ORCID 0000-0002-6025-530X
Jeong Seop MoonDepartment of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea.ORCID 0000-0002-5909-8159
Hyun Woo LeeDepartment of Internal Medicine, Gimpo Woori Hospital, Gimpo, Korea.ORCID 0000-0001-9197-5783
Hwoon-Yong JungDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0003-1281-5859
Woon Geon ShinDepartment of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.ORCID 0000-0002-9851-5576
Jae-Gyu KimDepartment of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.ORCID 0000-0002-4841-9404
Ju Yup LeeDepartment of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea.ORCID 0000-0003-0021-5354
Su Jung HanDepartment of Internal Medicine, Seoul Bumin Hospital, Seoul, Korea.ORCID 0009-0007-8482-2771
Sang-Wook KimDepartment of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea.ORCID 0000-0001-8209-540X
Joon Hyun ChoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.ORCID 0000-0002-3584-6300
Hyun LimDepartment of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.ORCID 0000-0001-6581-6420
Tae Ho KimDepartment of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.ORCID 0000-0003-2015-5176
Moo In ParkDepartment of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.ORCID 0000-0003-2071-6957
Gwang Ho BaikDepartment of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.ORCID 0000-0003-1419-7484
Ra Ri ChaDepartment of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, Korea.ORCID 0000-0001-6024-9201
Sang Kil LeeDepartment of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID 0000-0002-0721-0364
Jae J KimDepartment of Gastroenterology, Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu, Korea.ORCID 0000-0003-1161-8618

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background/Aims: Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of peptic ulcers. Tegoprazan, a novel potassium-competitive acid blocker, provides rapid and potent inhibition of acid production. This study evaluated whether tegoprazan 25 mg is non-inferior to lansoprazole 15 mg in preventing NSAID-induced peptic ulcer. Methods: In this double-blind, randomized, active-controlled, multicenter phase III trial, patients requiring NSAIDs for up to 24 weeks were randomized (1:1) to the tegoprazan or the lansoprazole group. The primary endpoint was the incidence of peptic ulcer at week 24 in the per-protocol population. Secondary endpoints were NSAID-induced gastrointestinal symptom-free rates. Safety outcomes included adverse drug reactions (ADRs) and serious adverse events (SAEs). Results: A total of 392 patients were randomized, and 269 patients were analyzed in the perprotocol set. Tegoprazan was non-inferior to lansoprazole for the prevention of gastroduodenal ulcers (p=0.0004). The heartburn-free rate at week 12 was higher in the tegoprazan group (p=0.0421), while other symptom-free rates did not differ significantly. In terms of safety, ADR and SAE rates were comparable and not significantly different. Conclusions: Tegoprazan was non-inferior to lansoprazole in preventing NSAID-induced peptic ulcers with excellent tolerance. Tegoprazan represents a clinically effective alternative gastroprotective therapy (ClinicalTrials.gov identifier NCT04840550).

Indexed as

Anti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsPeptic UlcerProton Pump InhibitorsAdultAgedDouble-Blind MethodFemaleHumansLansoprazoleMaleMiddle AgedTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalAnti-Ulcer AgentsLansoprazoleProton Pump InhibitorsAnti-Inflammatory agents, non-steroidalLansoprazolePeptic ulcerPotassium-competitive acid blockerTegoprazan

Identifiers

PMID42325011
PMCPMC13364759

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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 OpenQuestion graph.