drugset / Trial / NCT06959368

Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

NCT06959368

Phase 4 Recruiting 484 enrolled Asian Institute of Gastroenterology, India
RandomizedParallel-groupOpen-labelTreatment

Summary

Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.

Timeline

Start
2025-03-25
Primary completion
2026-03-25
Completion
2026-03-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 40 mg
Comparator Vonoprazan Other / unclassified 20 mg
Comparator Amoxicillin Other / unclassified 1 g
Comparator Clarithromycin Small molecule 500 mg