Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis
NCT ID: NCT06720610
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
216 participants
INTERVENTIONAL
2024-12-09
2025-06-27
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vonoprazan
Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively
Vonoprazan 20 mg
Vonoprazan PO, 20mg, once a day, 14 days.
Esomeprazole
Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively
Esomeprazole
Esomeprazole PO, 40mg, once a day, 14 days
Interventions
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Vonoprazan 20 mg
Vonoprazan PO, 20mg, once a day, 14 days.
Esomeprazole
Esomeprazole PO, 40mg, once a day, 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Ari Fahrial Syam
Dean of Faculty of Medicine Universitas Indonesia
Principal Investigators
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Ari F Syam, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Locations
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Hermina Jatinegara Hospital
East Jakarta, DKI Jakarta, Indonesia
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Hermina Kemayoran Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Hermina Bekasi Hospital
Bekasi, West Java, Indonesia
Hermina Depok Hospital
Depok, West Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Arlyando Saragih, MD
Role: primary
Ryan Herardi, MD
Role: primary
Andry Kurniawan, MD
Role: primary
Nikko Darnindro, MD
Role: primary
Aru Ariadno, MD
Role: primary
Other Identifiers
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24-08-1382
Identifier Type: OTHER
Identifier Source: secondary_id
INVEST01
Identifier Type: -
Identifier Source: org_study_id