MedTrace Logo

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

NCT07179159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2026-04-15

No results posted yet for this study

Summary

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Conditions

  • HELICOBACTER PYLORI INFECTIONS

Interventions

DRUG

14-day vonoprazan-amoxicillin dual therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid

DRUG

14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid

DRUG

14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

Sponsors & Collaborators

  • Longkou People's Hospital

    collaborator UNKNOWN

  • Qingdao Jimo People's Hospital

    collaborator OTHER

  • Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Dezhou Hospital Qilu Hospital of Shandong University

    collaborator OTHER

  • Zibo Maternal and Child Health Hospital

    collaborator OTHER

  • Guanxian County People's Hospital

    collaborator OTHER

  • Yantai Zhifu Hospital

    collaborator UNKNOWN

  • The 2nd People's Hospital of Dongying City

    collaborator UNKNOWN

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Yanqing Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07179159 on ClinicalTrials.gov