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NCT Number: NCT06959368

Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AIG hospitals

Hyderabad, Telangana, 500082, India

Location status: Recruiting

Location contact

AIG hospitals

CONTACT

[email protected]

040 4244 4222

Aniruddha Pratap Singh, MBBS, MD, DM

PRINCIPAL_INVESTIGATOR

Koduri Krithi Krishna, MBBS, MD, DNB

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 1 year

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

Secondary outcomes

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

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Krithi Krishna Koduri Doctor

CONTACT

[email protected]

+91 9870083545

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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