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Vonoprazan vs Esomeprazole H. pylori Eradication Phase 4 Study

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Summary

NIH registered a Phase 4 clinical trial (NCT07537634) comparing vonoprazan-based levofloxacin-containing triple therapy versus esomeprazole-based levofloxacin-containing triple therapy for Helicobacter pylori eradication in adults with dyspepsia. The randomized open-label study will randomly assign participants to 14-day treatment regimens with follow-up stool antigen testing at 4 weeks post-therapy to assess eradication efficacy and adverse effects.

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What changed

NIH registered a new Phase 4 clinical trial on ClinicalTrials.gov. The study (NCT07537634) will compare vonoprazan-based triple therapy (VAL regimen) against esomeprazole-based triple therapy (EAL regimen) for H. pylori eradication in adults with dyspepsia. Participants will be randomly assigned to receive 14 days of treatment with follow-up stool antigen testing at 4 weeks.

Healthcare providers and pharmaceutical companies should be aware of this comparative effectiveness research evaluating proton pump inhibitor-based regimens. The study results may inform future prescribing practices and clinical guidelines for H. pylori treatment.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication

Phase 4 NCT07537634 Kind: PHASE4 Apr 17, 2026

Abstract

The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.

The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.

Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.

Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.

Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.

Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.

Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.

Conditions: Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease

Interventions: vonoprazan-based triple therapy (VAL regimen), Esomeprazole-based triple therapy (EAL regimen)

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537634

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug therapy comparison Phase 4 research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Clinical Operations

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