Trial reportClinical and translational gastroenterology2019
Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.
Trial report in Clinical and translational gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02954848 (A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 10 mg Once-daily in the Treatment of Non-Erosive Gastroesophageal Reflux Disease), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 10 mg Once-daily in the Treatment of Non-Erosive Gastroesophageal Reflux Disease
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A systematic review and meta-analysis of randomized controlled trials: the effect of potassium-competitive acid blockers on nighttime symptoms of gastroesophageal reflux disease.Esophagus : official journal of the Japan Esophageal Society · 2026Pooled it
- Treatment Response With Potassium-competitive Acid Blockers Based on Clinical Phenotypes of Gastroesophageal Reflux Disease: A Systematic Literature Review and Meta-analysis.Journal of neurogastroenterology and motility · 2024Pooled it
- Comparison of acid-lowering drugs for endoscopy negative reflux disease: Systematic review and network Meta-Analysis.Neurogastroenterology and motility · 2023Pooled it
- Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease.Alimentary pharmacology & therapeutics · 2021Trial
- Evolving landscape of potassium-competitive acid blockers: toward disease-specific use beyond acid suppression.Journal of gastroenterology · 2026Review
- Reassessing Vonoprazan for Endoscopy-Negative Reflux Disease: A Systematic Review and Meta-Analysis.Digestive diseases and sciences · 2026Article
- 2025 Focused Update of the Seoul Consensus on Gastroesophageal Reflux Disease: Evidence-based Recommendations on Acid Suppressive Therapy.Journal of neurogastroenterology and motility · 2026Review
- Article
- Current pharmacological and procedural treatments for gastro-oesophageal reflux disease: comprehensive review.BJS open · 2025Review
- Vonoprazan and proton pump inhibitors: Which is superior forWorld journal of gastroenterology · 2025Article
- Integrated Analysis of Vonoprazan Safety for Symptomatic Gastro-Oesophageal Reflux Disease or Erosive Oesophagitis.Alimentary pharmacology & therapeutics · 2025Article
- Potassium-Competitive Acid Blockers and Proton Pump Inhibitors: The Dynamic Duo of Acid Blockers.Gastroenterology & hepatology · 2024Article
- Efficacy and safety of Jianpi Qinghua granules for non-erosive reflux disease with spleen deficiency and damp-heat syndrome: a multicenter, randomized, double-blind, placebo-controlled clinical trial.Frontiers in nutrition · 2024Article
- Vonoprazan: A New Potassium-Competitive Acid Blocker.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2023Review
- Incidence and type of adverse events in patients taking vonoprazan: A systematic review and meta-analysis.Therapeutic advances in gastroenterology · 2023Article
- [Treatment of Acid-related Diseases Using Potassium-competitive Acid Blockers].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2022Review
- Potassium-Competitive Acid Blockers: Present and Potential Utility in the Armamentarium for Acid Peptic Disorders.Gastroenterology & hepatology · 2022Article
- A Population Pharmacokinetic Model of Vonoprazan: Evaluating the Effects of Race, Disease Status, and Other Covariates on Exposure.Journal of clinical pharmacology · 2022Article
- Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2021.Journal of gastroenterology · 2022Review
- Trends in gastroesophageal reflux disease research: A bibliometric and visualized study.Frontiers in medicine · 2022Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
methodsThis phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
resultsCompared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity. DISCUSSION: Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.
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