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Search / Trial NCT06720610

Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Launched by INDONESIA UNIVERSITY · Dec 3, 2024

Trial Information

Current as of June 13, 2025

Not yet recruiting

Keywords

Erosive Esophagitis Vonoprazan Esomeprazole Gerd Q

ClinConnect Summary

This clinical trial, titled the Indonesian Study of Vonoprazan vs. Esomeprazole in Erosive Esophagitis, is designed to compare the effectiveness of two medications: vonoprazan and esomeprazole. Both drugs aim to relieve early symptoms in patients suffering from erosive esophagitis, a condition where the lining of the esophagus becomes inflamed and damaged. The study will help researchers understand how well each medication works and how safe they are for patients in Indonesia.

To participate, individuals must be over 18 years old and have been diagnosed with erosive esophagitis through an endoscopy. They should also have a specific score indicating the severity of their symptoms. Participants will take either vonoprazan (20 mg) or esomeprazole (40 mg) once a day for two weeks and will visit the clinic weekly for follow-ups. They will also keep a diary to track any side effects or changes in their symptoms. It’s important to note that individuals with certain medical conditions, allergies, or a history of surgery related to the esophagus or stomach will not be eligible for this trial.

Gender

ALL

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

About Indonesia University

Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.

Locations

Jakarta Pusat, Dki Jakarta, Indonesia

East Jakarta, Dki Jakarta, Indonesia

Jakarta Pusat, Dki Jakarta, Indonesia

Bekasi, Jawa Barat, Indonesia

Depok, Jawa Barat, Indonesia

Patients applied

0 patients applied

Trial Officials

Ari F Syam, MD

Principal Investigator

Fakultas Kedokteran Universitas Indonesia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported