Vonoprazan versus standard triple therapy for H. pylori eradication
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
Run by Asian Institute of Gastroenterology, India · NCT06959368 · Data updated 2026-11-12
This trial tests whether a vonoprazan-based regimen clears H. pylori better than standard proton-pump-inhibitor triple therapy in adults with confirmed H. pylori infection and dyspepsia or peptic ulcers.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 484 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | March 25, 2026 |
| Study ends | March 25, 2026 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT06959368 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with confirmed H. pylori infection (positive urea breath test or rapid urease test) who present with dyspepsia, GERD, or non-bleeding peptic ulcer and who can stop PPIs for two weeks are ideal candidates.
✕Probably not a fit
Patients with penicillin allergy, recent antibiotic use, prior H. pylori eradication therapy, pregnancy or lactation, major comorbidities (e.g., cirrhosis, chronic kidney or lung disease), anticoagulation/NSAID use, or taking drugs that interact with the study medications are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with confirmed H. pylori infection who present with dyspepsia, GERD, or non-bleeding peptic ulcer are assigned to receive either vonoprazan 20 mg or esomeprazole 40 mg together with amoxicillin 1 g and clarithromycin 500 mg as part of triple therapy. Participants must be 18–80 years old, off proton-pump inhibitors for two weeks, and have a positive urease or urea breath test at baseline. H. pylori eradication is determined after treatment using standard testing methods, and patients with recent antibiotic exposure, prior H. pylori therapy, significant comorbidities, or contraindicated medications are excluded. The trial compares eradication rates, safety, and tolerability between the vonoprazan-based and PPI-based regimens in a real-world, post-marketing (Phase 4) setting.
Why it matters
Potential benefit: If successful, vonoprazan-based triple therapy could produce higher H. pylori cure rates and fewer treatment failures in settings with antibiotic resistance.
How similar studies have gone: Previous clinical studies, particularly in East Asia, have shown that vonoprazan-based triple therapy can achieve higher H. pylori eradication rates than PPI-based regimens, supporting this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
AIG hospitals
Hyderabad, Telangana, India Recruiting
Study contacts
- Study coordinator: Krithi Krishna Koduri Doctor
- Email: drkrithivk@gmail.com
- Phone: +91 9870083545
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.