drugset / Trial / NCT05614934

Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

NCT05614934

Phase 4 Completed 132 enrolled Alexandria University
NaParallel-groupOpen-labelTreatment

Summary

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens. The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Timeline

Start
2022-06-11
Primary completion
2023-05-01
Completion
2023-05-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 1 g Oral
Comparator Clarithromycin Small molecule 500 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral