RecruitingPhase 4NCT06929962

VA Dual Sequential Therapy

Vonoprazan-Amoxicillin Dual Sequential Therapy For Helicobacter Pylori-infected Treatment-naive Patients:A Randomized, Open-label, Parallel-controlled , Multicenter Clinical Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

600 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics. Based on this, the investigators propose a modified sequential therapy, where the first phase uses vonoprazan combined with amoxicillin, and the second phase increases the amoxicillin dosage, forming a high-dose amoxicillin regimen. This new treatment strategy combines the staged nature of sequential therapy with the advantages of high-dose dual therapy, gradually increasing the drug dosage to help patients adapt and reduce side effects (such as nausea, vomiting, and diarrhea), thereby improving patient tolerance. The primary aim of this study is to compare the vonoprazan combined with high-dose amoxicillin sequential therapy with standard dual therapy (14-day regimen) in terms of Hp eradication rates, efficacy, side effect incidence, and patient compliance, to evaluate its improved effectiveness. Additionally, the study will explore the impact of a shortened treatment duration on the modified dual sequential therapy's efficacy for Hp infection. Eligible participants in this study will be randomly assigned to one of the following three treatment groups based on a pre-generated randomization sequence: Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VADT-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 1: Vonoprazan combined with amoxicillin dual sequential therapy for 14 days (VAST-14): Days 1 to 7: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 8 to 14: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 2: Vonoprazan combined with amoxicillin dual sequential therapy for 10 days (VAST-10): Days 1 to 5: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 6 to 10: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vonoprazan and Amoxicillin for 14 days, a drug called Vonoprazan and Amoxicillin for the first 5 days, and others for people with helicobacter pylori infection. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVonoprazan and Amoxicillin for the first 7 days

20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 7 days

DRUGVonoprazan and Amoxicillin for the first 5 days

20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 5 days

DRUGVonoprazan and Amoxicillin for the second 7 days

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 7 days

DRUGVonoprazan and Amoxicillin for the second 5 days

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 5 days

DRUGVonoprazan and Amoxicillin for 14 days

20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06929962


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