Evidence map›Paper›PMID 28119763›Full record

ArticleCurrent therapeutic research, clinical and experimental

Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

Yoshikazu Kinoshita, Yuuichi Sakurai, Madoka Shiino, Kentaro Kudou, Akira Nishimura, Takuya Miyagi, Katsuhiko Iwakiri, Eiji Umegaki, Kiyoshi Ashida

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Current therapeutic research, clinical and experimental. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT01474369 phase3completednot on this map

A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.

TypeinterventionalSponsorTakedaRan2011 to 2013Enrolled827ConditionsNon-erosive Gastroesophageal Reflux DiseaseArmsTAK-438, Placebo
NCT04028466 phase4terminatednot on this map

Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features in a Primary Care Setting: A Pragmatic, Randomized, Single Blind Study

TypeinterventionalSponsorSt. Luke's Medical Center, PhilippinesRan2019 to 2020Enrolled82ConditionsGERD, Gastro Esophageal RefluxArmsVonoprazan, Omeprazole
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  13. [Drug Therapy for Gastroesophageal Reflux Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  14. Article
  15. Article
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  17. Article
  18. Updates in the Management of Erosive Esophagitis.The Journal of family practice · 2023
    Article
  19. [Role of Potassium-competitive Acid Blockers in the Treatment of Gastric Acid-related Disorders].The Korean journal of helicobacter and upper gastrointestinal research · 2023
    Review
  20. 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

9 authors at 5 institutions in 1 country.

Yoshikazu KinoshitaDepartment of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.
Yuuichi SakuraiTakeda Development Center Japan, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Madoka ShiinoTakeda Development Center Japan, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Kentaro KudouTakeda Development Center Japan, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Akira NishimuraTakeda Development Center Japan, Takeda Pharmaceutical Company Ltd, Osaka, Japan.
Takuya MiyagiDepartment of Gastroenterology and Hepatology, Yao Municipal Hospital, Yao, Japan.
Katsuhiko IwakiriDepartment of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
Eiji UmegakiDepartment of Gastroenterology, Kobe University Graduate School of Medicine, Kobe, Japan.
Kiyoshi AshidaDepartment of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.
Takeda (Japan) · JPKobe University · JPNippon Medical School · JPRakuwakai Otowa Hospital · JPShimane University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor many patients, current treatments do not adequately resolve heartburn in nonerosive reflux disease (NERD).

objectiveTo compare vonoprazan and placebo with respect to the frequency and severity of heartburn in patients with NERD.

methodsThis Phase III, double-blind, placebo-controlled, parallel-group, multicenter study included patients in Japan aged ≥20 years with Grade N or M NERD and recurrent acid reflux symptoms. Patients were blinded and randomized 1:1:1 to receive placebo or vonoprazan 10 mg or 20 mg. The primary efficacy outcome was the proportion of days without heartburn measured by patient scores during the 4-week treatment period.

resultsEight hundred twenty-seven patients were randomized (placebo: n = 278, vonoprazan 10 mg: n = 278, and vonoprazan 20 mg: n = 271). Median proportion of days without heartburn was 7.4% (placebo), 10.3% (vonoprazan 10 mg), and 12.0% (vonoprazan 20 mg). Proportion of days without heartburn was not statistically significant between the vonoprazan and placebo groups (

conclusionsVonoprazan at doses of 10 mg and 20 mg are not superior to placebo with respect to proportion of days without heartburn, whereas the mean severity of heartburn is lower with vonoprazan compared with placebo in patients with NERD. ClinicalTrials.gov identifier: NCT01474369.

Indexed as

gastroesophageal refluxheartburnNERDnonerosive gastroesophageal reflux diseasepotassium-competitive acid blockersvonoprazan

Identifiers

PMID28119763
PMCPMC5238607
OpenAlexW2563981115

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.