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A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Start date: Jun 7, 2025 to Dec 20, 2025v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 10, 2025 to Jun 7, 2025
    • Site details revised
    v3
  3. Minor Interventions: medicine (Drug) to Esomeprazole 40mg (Drug), Vonoprazan (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 139 words
    v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary Objective • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily. Secondary Objectives * To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events across treatment groups.
Trial Details
NCT Number NCT06953986
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)
GERD
Related terms Gastroesophageal Reflux
Enrollment 414 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov