drugset / Trial / NCT06250634

Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection

NCT06250634

RandomizedParallel-groupOpen-labelTreatment

Summary

This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.

Timeline

Start
2024-02-10
Primary completion
2024-05-10
Completion
2024-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 750 mg
Subject Amoxicillin Other / unclassified 1000 mg
Comparator Clarithromycin Small molecule 500 mg
Subject Esomeprazole Small molecule 20 mg
Subject Vonoprazan Other / unclassified 20 mg
Comparator colloidal bismuth tartrate Unknown 165 mg