Evidence map›Paper›PMID 31409606›Full record

Trial reportGut2020

Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis.

Yinglian Xiao, Shutian Zhang, Ning Dai, Guijun Fei, Khean-Lee Goh, Hoon Jai Chun, Bor-Shyang Sheu, Chui Fung Chong, Nobuo Funao, Wen Zhou and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02388724 (A Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis), which is not on this map. Cited by 75 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 10 pooled it
8.5field-weighted citation impact, top 2% of its field
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.

NCT02388724 phase3completednot on this map

A Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis

TypeinterventionalSponsorTakedaRan2015 to 2017Enrolled481ConditionsErosive EsophagitisArmsVonoprazan, Lansoprazole, Vonoprazan Placebo, Lansoprazole Placebo
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 10 syntheses or guidelines pooled it, 142 citations in OpenAlex.

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  5. Vonoprazan versus lansoprazole in erosive esophagitis - A systematic review and meta-analysis of randomized controlled trials.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2023
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  14. [The efficacy of vonoprazan fumarate in the treatment of laryngopharyngeal reflux disease evaluated by the Chinese version of the RSS-12 scale].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2025
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15 more citing papers are in PubMed but not listed here.

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

11 authors at 10 institutions in 7 countries.

Yinglian XiaoDepartment of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Shutian ZhangDepartment of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Ning DaiDepartment of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, China.
Guijun FeiDepartment of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.
Khean-Lee GohDivision of Gastroenterology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Hoon Jai ChunDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Republic of Korea.
Bor-Shyang SheuDepartment of Internal Medicine, National Cheng Kung University Hospital and Tainan Hospital, Tainan, Taiwan.ORCID 0000-0002-2164-138X
Chui Fung ChongGastroenterology Therapeutic Area Unit, Takeda Development Center Asia, Singapore, Singapore.
Nobuo FunaoTakeda Development Center Japan, Takeda Pharmaceutical Company, Osaka, Japan.
Wen ZhouDepartment of Clinical Science, Takeda Pharmaceutical Company, Cambridge, Massachusetts, USA.
Minhu ChenDepartment of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China chenminhu@mail.sysu.edu.cn.ORCID 0000-0001-9925-135X
Sun Yat-sen University · CNCapital Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNKorea University · KRNational Cheng Kung University Hospital · TWSir Run Run Shaw Hospital · CNTakeda (Japan) · JPTakeda (Singapore) · SGTakeda (United States) · USUniversity of Malaya · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo establish the non-inferior efficacy of vonoprazan versus lansoprazole in the treatment of Asian patients with erosive oesophagitis (EO).

designIn this phase III, double-blind, multicentre study, patients with endoscopically confirmed EO were randomised 1:1 to receive vonoprazan 20 mg or lansoprazole 30 mg, once daily for up to 8 weeks. The primary endpoint was EO healing rate at 8 weeks. The secondary endpoints were EO healing rates at 2 and 4 weeks. Safety endpoints included treatment-emergent adverse events (TEAEs).

resultsIn the vonoprazan (n=238) and lansoprazole (n=230) arms, 8-week EO healing rates were 92.4% and 91.3%, respectively (difference 1.1% (95% CI -3.822% to 6.087%)). The respective 2-week EO healing rates were 75.0% and 67.8% (difference 7.2% (95% CI -1.054% to 15.371%)), and the respective 4-week EO healing rates were 85.3% and 83.5% (difference 1.8% (95% CI -4.763% to 8.395%)). In patients with baseline Los Angeles classification grade C/D, 2-week, 4-week and 8-week EO healing rates were higher with vonoprazan versus lansoprazole (2 weeks: 62.2% vs 51.5%, difference 10.6% (95% CI -5.708% to 27.002%); 4 weeks: 73.3% vs 67.2%, difference 6.2% (95% CI -8.884 to 21.223); and 8 weeks: 84.0% vs 80.6%, difference 3.4% (95% CI -9.187% to 15.993%)). Overall, EO healing rates appeared higher with vonoprazan versus lansoprazole. TEAE rates were 38.1% and 36.6% in the vonoprazan and lansoprazole group, respectively.

conclusionOur findings demonstrate the non-inferior efficacy of vonoprazan versus lansoprazole in terms of EO healing rate at 8 weeks in this population. Safety outcomes were similar in the two treatment arms. TRIAL REGISTRATION NUMBER: NCT02388724.

Indexed as

AdultAgedDouble-Blind MethodDrug Administration ScheduleEsophagitis, PepticFemaleHumansLansoprazoleMaleMiddle AgedProton Pump InhibitorsPyrrolesSeverity of Illness IndexSulfonamidesTreatment OutcomeWound Healing1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineLansoprazoleProton Pump InhibitorsPyrrolesSulfonamideserosive oesophagitisgastric acidgastro-oesophageal reflux diseaseproton pump inhibition

Identifiers

PMID31409606
PMCPMC6984055
OpenAlexW2968018058

What OpenQuestion holds

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LicenceCC BY-NC
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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.