Vonoprazan vs Esomeprazole H. pylori Eradication Phase 4 Study
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.
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, 2026GovPing 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.
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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