Evidence map›Paper›PMID 26935876›Full record

Trial reportGut2016

Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study.

Kazunari Murakami, Yuuichi Sakurai, Madoka Shiino, Nobuo Funao, Akira Nishimura, Masahiro Asaka

4 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 243 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
243citing papers in PubMed, 15 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.

NCT01505127 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori

TypeinterventionalSponsorTakedaRan2012 to 2013Enrolled650ConditionsH. Pylori InfectionArmsTAK-438, Lansoprazole, Amoxicillin, Clarithromycin
NCT04901663 phase4completednot on this mapstarted 2021, after this paper: background citation

Comparison of Vonoprazan and Amoxicillin Dual Therapy With Standard Triple Therapy With Proton Pump Inhibitor for Helicobacter Pylori Eradication; a Randomized Control Trial

TypeinterventionalSponsorDow University of Health SciencesRan2021 to 2021Enrolled179ConditionsHelicobacter Pylori InfectionArmsOmeprazole 20 MG Capsule, Amoxicillin 1000 MG, Clarithromycin 500 MG, Vonoprazan 20 MG, Amoxicillin 1000 MG
NCT06318104 phase4unknown statusnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days

TypeinterventionalSponsorHospital General de México Dr. Eduardo LiceagaRan2024 to 2025Enrolled160ConditionsHelicobacter Pylori InfectionArmsTegoprazan, Esomeprazole 40mg
NCT07293910 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection

TypeinterventionalSponsorTanta UniversityRan2026 to 2026Enrolled66ConditionsHELICOBACTER PYLORI INFECTIONS, Helicobacter Infection, Helicobacter Pylori Gastrointestinal Tract Infection, Helicobacter Pylori Infected PatientsArmsVonoparazan, Vitamin D, Probiotic, Amoxicillin, Clarithromycin 500 mg
3 · Its place in the literature

Who cites it

243 citing papers in PubMed, 15 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. [Evidence-Based Guidelines for the Diagnosis and Treatment ofThe Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2026
    Guideline
  4. Guideline
  5. Pooled it
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  7. First regional consensus on the management ofWorld journal of gastroenterology · 2025
    Guideline
  8. Research trends of nanomaterials inFrontiers in pharmacology · 2025
    Pooled it
  9. Pooled it
  10. Treatment ofWorld journal of gastroenterology · 2024
    Pooled it
  11. Guidelines on optimizing the use of proton pump inhibitors: PPI stewardship.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2023
    Guideline
  12. Pooled it
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  14. Guideline
  15. Pooled it
  16. Trial
  17. Trial
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  19. Efficacy and safety of triple therapy with vonoprazan forWorld journal of gastroenterology · 2025
    Trial
  20. Trial

183 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Kazunari MurakamiDepartment of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan.
Yuuichi SakuraiTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Madoka ShiinoTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Nobuo FunaoTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Akira NishimuraTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Masahiro AsakaHealth Sciences University of Hokkaido, Hokkaido, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to assess the efficacy, safety and tolerability of vonoprazan, a novel potassium-competitive acid blocker, as a component of Helicobacter pylori eradication therapy.

designA randomised, double-blind, multicentre, parallel-group study was conducted to verify the non-inferiority of vonoprazan 20 mg to lansoprazole 30 mg as part of first-line triple therapy (with amoxicillin 750 mg and clarithromycin 200 or 400 mg) in H pylori-positive patients with gastric or duodenal ulcer history. The first 50 patients failing first-line therapy with good compliance also received second-line vonoprazan-based triple therapy (with amoxicillin 750 mg and metronidazole 250 mg) as an open-label treatment.

resultsOf the 650 subjects randomly allocated to either first-line triple therapy, 641 subjects completed first-line therapy and 50 subjects completed second-line therapy. The first-line eradication rate (primary end point) was 92.6% (95% CI 89.2% to 95.2%) with vonoprazan versus 75.9% (95% CI 70.9% to 80.5%) with lansoprazole, with the difference being 16.7% (95% CI 11.2% to 22.1%) in favour of vonoprazan, thus confirming the non-inferiority of vonoprazan (p<0.0001). The second-line eradication rate (secondary end point) was also high (98.0%; 95% CI 89.4% to 99.9%) in those who received second-line therapy (n=50). Both first-line triple therapies were well tolerated with no notable differences. Second-line triple therapy was also well tolerated.

conclusionVonoprazan is effective as part of first-line triple therapy and as part of second-line triple therapy in H pylori-positive patients with a history of gastric or duodenal ulcer. TRIAL REGISTRATION NUMBER: NCT01505127.

Indexed as

Anti-Bacterial AgentsHelicobacter InfectionsHelicobacter pyloriLansoprazolePyrrolesSulfonamidesAdultAmoxicillinBreath TestsClarithromycinDouble-Blind MethodDrug Administration ScheduleDrug MonitoringDrug Therapy, CombinationFemaleHumans1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineAmoxicillinAnti-Bacterial AgentsClarithromycinLansoprazoleMetronidazoleProton Pump InhibitorsPyrrolesSulfonamidesANTIBIOTIC THERAPYCLINICAL TRIALSHELICOBACTER PYLORI INFECTIONHELICOBACTER PYLORI - TREATMENT

Identifiers

PMID26935876
PMCPMC5036253

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.