drugset / Trial / NCT07720037

Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial

NCT07720037 ↗

Phase 4 Not yet recruiting 232 enrolled Shandong University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.

Timeline

Start
2026-09-30
Primary completion
2026-09-30
Completion
2028-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Vonoprazan Other / unclassified 20 mg —
Background Amoxicillin Other / unclassified 1000 mg —