Набор по приглашению NCT07437768

Vonoprazan Test for PPI Refractory GERD

Без фазы С лечением Refractory GERD NERD PCAB

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: Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®).
Кому может быть актуально: Состояния в реестре: Refractory GERD, NERD, PCAB. Базовые параметры: 20 лет — 75 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: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease

Обзор

Among patients suffering from gastroesophageal reflux disease (GERD) symptoms, esophageal pH monitoring and the assessment of symptom-reflux correlation can identify two distinct subgroups characterized by normal acid exposure: functional heartburn and reflux hypersensitivity. Given the absence of abnormal acid exposure in these groups, conventional antacid therapies often yield unsatisfactory clinical outcomes. Therefore, in cases of PPI-refractory GERD, it is hypothesized that patients with underlying abnormal acid reflux will respond to Vonoprazan, a more potent potassium-competitive acid blocker (P-CAB). Conversely, those whose symptoms are unrelated to acid reflux are expected to show poor response. For future refractory patients without definitive endoscopic evidence of GERD (such as Los Angeles Grade B, C, or D esophagitis, peptic stricture, or histologically confirmed Barrett's esophagus), a Vonoprazan therapeutic trial could potentially bypass the need for invasive high-resolution manometry (HRM) and 24-hour pH-impedance monitoring. Evaluating the efficacy of Vonoprazan may offer diagnostic insights while minimizing patient discomfort and reducing overall healthcare expenditures.

Вмешательства

Препарат Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)
Participants undergoing HRM and 24-hour pH-impedance monitoring were enrolled after providing informed consent. Baseline GERD-related questionnaires were administered on the day of the procedure. Patients then received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®). After four weeks, patients returned for a follow-up visit to review their diagnostic reports and complete a second set of questionnaires. Final treatment strategies were adjusted according to the test findings.

Первичные конечные точки

All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire [Срок оценки: 4 weeks]

Вторичные конечные точки (3)

The Reflux Symptom Index (RSI) [Срок оценки: 4 weeks]
The 5-item Brief Symptom Rating Scale (BSRS-5) [Срок оценки: 4 weeks]
The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

Patients aged between 20 and 75 years.
Outpatients at Fu Jen Catholic University Hospital who had undergone esophagogastroduodenoscopy (EGD) within the past year.
Presence of persistent GERD symptoms, including acid regurgitation, heartburn, chest pain, globus sensation, or chronic cough. PPI-refractory GERD, defined as persistent symptoms despite receiving at least 8 weeks of standard-dose proton pump inhibitor (PPI) therapy (GerdQ > = 8).
Scheduled to undergo high-resolution manometry (HRM) and 24-hour esophageal pH-impedance monitoring.
Patients with a history of any grade of erosive esophagitis confirmed by gastroscopy.