Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

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.

Inclusion criteria

• Patients aged >18 years with a GERD-Q score of 8.
• Diagnosed with erosive esophagitis by endoscopy. (Los Angeles Classification A-D)
• Patients are willing to undergo a series of therapeutic management.

Exclusion criteria

• Patients with a history of allergy to PCAB or PPI groups.
• Patients with gastric and/or duodenal ulcers.
• Patients with Helicobacter pylori infection.
• Patients with a history of significant systemic disease disorders affecting the esophagus and stomach.
• Patients with a history of malignant disease related to the esophagus and/or stomach.
• Patients with a history of esophageal and/or gastric surgery.
• Pregnant patients