Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

NCT06959368 | Recruiting Phase 4

• 1 other identifier: VECTOR-01
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  The primary outcome measurement is to assess the eradication of H. pylori i.e. negative UBT or stool antigen test 4 weeks after treatment

  1 year

Secondary Outcomes (1)

• Assessment of adverse events and eradication rates in antibiotic-resistant strains.

  1 year

Study Arms (2)

Vonoprazan triple therapy

ACTIVE COMPARATOR

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

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

Standard triple therapy

ACTIVE COMPARATOR

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

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

Interventions

Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg 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; Vonoprazan triple therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Esomeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Central Study Contacts

Krithi Krishna Koduri Doctor

CONTACT

+91 9870083545; drkrithivk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: March 25, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)