Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Sponsor
Indonesia University
Study ID
NCT06720610
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vonoprazan 20 mg — DRUG
    Vonoprazan PO, 20mg, once a day, 14 days.
  • Esomeprazole — DRUG
    Esomeprazole PO, 40mg, once a day, 14 days

Study Details

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.

Key Dates

Start date
Dec 9, 2024
Status verified
Dec 2024
Primary completion
Apr 25, 2025
Completion
Jun 27, 2025

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vonoprazan
    Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively
  • Active Comparator: Esomeprazole
    Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively

Primary Outcome Measure

Number of Participants with Symptoms Resolution of Erosive Esophagitis [ Time Frame: 14 days (two weeks) ]

Central Contacts

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