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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 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • Helicobacter Infection
  • Vonoprazan
  • Amoxicillin

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

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2026-09-30
Completion
2028-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07720037 on ClinicalTrials.gov