NCT06720610

Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Comparison of the Effectiveness of Vonoprazan and Esomeprazole in Improving Initial Symptoms in Patients with Erosive Esophagitis: a Double-Blind Randomized Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on the calculation using the formula for comparing two population proportions, the minimum estimated sample size is 97 samples for each group. Considering a potential 10% drop-out rate, the estimated sample size increases to 108 samples per group. Therefore, the total minimum sample required for this study is 216 samples for both groups. All the patients will screened using the Gastro Esophageal Reflux Disease-Quetionnaire (6 questions, 4 answer options, covering the last 7 days) and collected through RedCap. After that all eligible patients will undergo endoscopic examination that performed by gastroenterology specialists or trained internists. Included patients who consume any Proton Pump Inhibiotr or Potassium-competitive acid blockers within 2 weeks prior to this study will undergo wash-out period for 2 weeks. Patients are monitored weekly during the wash-out period. Medication reminders are sent via instant messaging at least twice per week. Adverse Event will be monitored by research assistants in coordination with the patient's primary physician. All the data will analyzed blindly with Chi-square or Fisher's exact test for categorical data and logistic regression for confounding factors. At the end of the study, the pharmacy team will reveal the group allocation.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	Vonoprazan 20 mg	Vonoprazan PO, 20mg, once a day, 14 days.
DRUG	Esomeprazole	Esomeprazole PO, 40mg, once a day, 14 days

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-04-25
• Completion: 2025-06-27
• First posted: 2024-12-06
• Last updated: 2024-12-17

Locations

5 sites across 1 country: Indonesia