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ClinicalTrials.gov ID

NCT06720610

Lead Sponsor

Indonesia UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

216Estimated

Last Update Posted

Dec 17, 2024Actual

Start Date

Dec 9, 2024Estimated

Primary Completion Date

Apr 25, 2025Estimated

Completion Date

Jun 27, 2025Estimated

Official Title

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

Brief 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.

• Erosive Esophagitis

• Vonoprazan 20 mg
• Esomeprazole

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Indonesia UniversityOTHER

nikkodarnindro@gmail.com+628129734458

roeariadno@gmail.com+6281384473476