Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Vonoprazan 20 mg, Esomeprazole.
- Кому может быть актуально
- Состояния в реестре: Erosive Esophagitis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Индонезия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Comparison of the Effectiveness of Vonoprazan and Esomeprazole in Improving Initial Symptoms in Patients with Erosive Esophagitis: a Double-Blind Randomized Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Vonoprazan 20 mg
Vonoprazan PO, 20mg, once a day, 14 days. - Препарат Esomeprazole
Esomeprazole PO, 40mg, once a day, 14 days
Первичные конечные точки
- Number of Participants with Symptoms Resolution of Erosive Esophagitis [Срок оценки: 14 days (two weeks)]
Вторичные конечные точки (1)
- Number of Participants with Adverse Event [Срок оценки: 14 days (two weeks)]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Индонезия · 5 центров
- Hermina Jatinegara Hospital — East Jakarta
- Cipto Mangunkusumo Hospital — Jakarta Pusat
- Hermina Kemayoran Hospital — Jakarta Pusat
- Hermina Bekasi Hospital — Bekasi
- Hermina Depok Hospital — Depok
Идентификаторы
NCT: NCT06720610 · INVEST01 · 24-08-1382