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Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Study acronym: INVEST
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 17, 2024 (before its estimated April 25, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint revised
    • Secondary endpoint revised
    • Study description expanded, about 4 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in Erosive Esophagitis Patients. It will also learn about the safety of both modalities. The main questions it aims to answer are: How does the effectiveness of Vonoprazan compare with Esomeprazole in improving early symptoms of erosive esophagitis patients in the Indonesian population? Researchers will compare drug vonoprazan to a esomeprazole with a look-alike packaging to see their effect to reduce early symptoms of erosive esophagitis. Participants will: * Take drug vonoprazan 20mg or esomeprazole 40mg one time every day for 2 weeks * Visit the clinic once every weeks for followup (Gastro Esophageal Reflux Disease-Quetionnaire measurement) * Keep a diary of their adverse effect occurence and every variable data based on Gastro Esophageal Reflux Disease-Questionnaire.
Trial Details
NCT Number NCT06720610
Lead Sponsor Universitas Indonesia
Conditions
(from sponsor)		 Erosive Esophagitis
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov