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NOT YET RECRUITING
NCT07720037
PHASE4

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

Sponsor: Shandong University

View on ClinicalTrials.gov

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.

Official title: Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori: A Multicenter, Non-Inferiority Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2026-07-30

Completion Date

2028-05-30

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

10-day group

vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days

DRUG

14-day group

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days