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RECRUITING
NCT06959368
PHASE4

Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Sponsor: Asian Institute of Gastroenterology, India

View on ClinicalTrials.gov

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.

Official title: A Randomised Controlled Trial Comparing Vonoprazan Triple Therapy (Vonoprazan, Amoxicillin, Clarithromycin), and Standard Triple Therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter Pylori Eradication in Indian Population. VECTOR Trial - Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

484

Start Date

2025-03-25

Completion Date

2026-03-25

Last Updated

2025-06-11

Healthy Volunteers

No

Interventions

DRUG

Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg

Participants will receive the respective drug regimens twice daily. The Vonoprazan triple therapy arm will administer Vonoprazan 20 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily. The Standard triple therapy arm will administer Esomeprazole 40 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily.

Locations (1)

AIG hospitals

Hyderabad, Telangana, India