NCT06959368 Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
| NCT ID | NCT06959368 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 484 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2026-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 484 participants in total. It began in 2025-03-25 with a primary completion date of 2026-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06959368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06959368 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06959368 currently recruiting?
Yes, NCT06959368 is actively recruiting participants. Contact the research team at drkrithivk@gmail.com for enrollment information.
Where is the NCT06959368 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT06959368 clinical trial?
NCT06959368 is sponsored by Asian Institute of Gastroenterology, India. The trial plans to enroll 484 participants.