drugset / Trial / NCT02827942

Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication

NCT02827942

Phase 3 Completed 112 enrolled Hamamatsu University
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

Timeline

Start
2016-07-01
Primary completion
2018-12-31
Completion
2019-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 500 mg
Subject Amoxicillin Other / unclassified 750 mg
Comparator Clarithromycin Small molecule 200 mg
Comparator Metronidazole Small molecule 250 mg
Subject Vonoprazan Other / unclassified 20 mg

Indications