Идёт набор NCT06955520

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Без фазы С лечением GERD

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, Esomeprazole 40mg.
Кому может быть актуально: Состояния в реестре: GERD. Базовые параметры: 18 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: Индия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis. Primary Objective: • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg. Secondary Objectives * To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events in each treatment group.

Подробное описание

Study Type:

• Randomized, Open-Label, Two-Arm, Non-Inferiority Trial

Randomization and Blinding:

* Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg. * Stratification: Based on LA grade (B vs. C/D) at baseline. * Blinding: Open-label study, but outcome assessors will be blinded.

Study Timeline:

1. All post-POEM patients receive Esomeprazole 40 mg for 2 months. 2. PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists). 3. At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks. 4. At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.

Study Arms:

* Arm A: Vonaprazan 20 mg once daily for 8 weeks * Arm B: Esomeprazole 40 mg once daily for 8 weeks

Study Procedures:

Baseline Assessment (3 Months Post-POEM, Before Randomization)

* Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis. * GERD-Q Score assessment. * Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit) * GERD-Q Score assessment.

End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)

* Upper GI Endoscopy to assess healing of reflux esophagitis. * GERD-Q Score reassessment. * Final adverse event reporting.

Вмешательства

Препарат Vonoprazan
a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
Препарат Esomeprazole 40mg
It is a proton pump inhibitor which reduces the excessive acid secretion in the stomach and it heals grade B esophagitis (\>5mm ulcer between two mucosal folds in esophagus)

Первичные конечные точки

• Endoscopic healing of reflux esophagitis at 8 weeks (absence of LA grade B or higher esophagitis). [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Improvement in GERD-Q scores at 8 weeks [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Age ≥18 years
History of POEM for achalasia
Endoscopic confirmation of LA grade B, C, or D reflux esophagitis at 3 months post-POEM
GERD symptoms (heartburn, regurgitation) for ≥4 weeks
Willingness to provide informed consent and comply with study procedures