Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

NCT ID: NCT06959368

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-03-25

Brief 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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vonoprazan triple therapy

• Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Standard triple therapy

• Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult (18 years - 80 years)
• Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer
• 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy
• Off PPIs for 2 weeks

Exclusion Criteria

• Penicillin allergy
• Recent use of antibiotics in the past 1 month
• Previous H. pylori therapy
• Intestinal metaplasia, gastric cancer, bleeding peptic ulcer
• Patient who is unable to understand study protocol or not consenting
• Pregnancy, lactation
• Patient on anticoagulation, NSAIDs
• Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs
• Cirrhosis, Chronic kidney disease, chronic lung disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AIG hospitals

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Krithi Krishna Koduri Doctor

Role: CONTACT

drkrithivk@gmail.com

+91 9870083545

Facility Contacts

AIG hospitals

Role: primary

info@aighospitals.com

040 4244 4222

Other Identifiers

VECTOR-01

Identifier Type: -

Identifier Source: org_study_id