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Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated June 11, 2025 (before its estimated March 25, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Active, Not Recruiting to Recruiting
    • Study description shortened, about 163 words
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06959368
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)		 Helicobacter Pylori Infection
Enrollment 484 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov