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Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

NCT06720610 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

Vonoprazan 20 mg

Vonoprazan PO, 20mg, once a day, 14 days.

DRUG

Esomeprazole

Esomeprazole PO, 40mg, once a day, 14 days

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Ari F Syam, MD · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2025-04-25
Completion
2025-06-27

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720610 on ClinicalTrials.gov