drugset / Trial / NCT06414707

Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori

NCT06414707

Phase 3 Completed 320 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this Randomized controlled trial is to assessment Efficacy of Vonoprazan versus Proton Pump Inhibitors in Combination with Antibiotics as a triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori (H. pylori). This randomized controlled study was performed on 2 groups of Egyptian patients diagnosed with dyspepsia; group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days and group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. All patients of the two groups were followed up for persistence of infection 8 weeks after the end of treatment by testing fecal H. pylori antigen (Ag).

Timeline

Start
2023-10-12
Primary completion
2024-04-04
Completion
2024-04-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pantoprazole Other / unclassified 40 mg Oral
Comparator Vonoprazan Other / unclassified 20 mg Oral
Comparator Amoxicillin Other / unclassified 1 g Oral
Comparator Levofloxacin Small molecule 500 mg Oral