A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Официальное название

Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Обзор

Primary Objective • To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily. Secondary Objectives * To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events across treatment groups.

Подробное описание

Study Design:

* This is a randomized, open-label, parallel-group, non-inferiority trial. Randomization and Blinding * Participants will be randomized in a 1:1:1 ratio to receive Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks. * Randomization will be stratified by baseline severity of esophagitis (LA grade B vs. C/D). * The study will be open-label, but the outcome assessors will be blinded. Study Arms

1. Vonaprazan 10 mg once daily 2. Vonaprazan 20 mg once daily 3. Esomeprazole 40 mg once daily

Duration: * 8 weeks of treatment, followed by endoscopic assessment and symptom evaluation.

I

Study Procedures:

Baseline :

* Perform upper GI endoscopy to confirm LA grade B or higher esophagitis. * Record baseline GERD-Q score. * Randomize participants into one of the three treatment groups. * Dispense study medication. Follow-up (Week 4 - Interim Assessment) * Assess GERD-Q score. * Monitor adherence and adverse events. End-of-Treatment (Week 8 - Primary Outcome Assessment) * Repeat upper GI endoscopy to assess mucosal healing. * Reassess GERD-Q score. * Collect adverse event data. * Conclude study participation.

Вмешательства

• Препарат Vonoprazan
  Vonaprazon is potassium competitive acid blockers
• Препарат Esomeprazole 40mg
  esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach

Первичные конечные точки

• • Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). [Срок оценки: 8 weeks]
• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis). [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• • GERD-Q score improvement at 8 weeks (compared to baseline). [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Adults ≥18 years of age.
• Endoscopically confirmed LA grade B, C, or D reflux esophagitis.
• GERD symptoms (heartburn, regurgitation) for at least 4 weeks prior to enrollment.
• Willing to provide informed consent and comply with study procedures.

Критерии исключения

• Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks.
• Prior esophageal surgery or radiation therapy.
• Barrett's esophagus, esophageal stricture, or malignancy.
• Pregnant or breastfeeding women.
• History of PPI-refractory GERD or severe gastroparesis.
• Significant hepatic or renal impairment (ALT/AST >3× ULN, eGFR <30 mL/min).
• Use of NSAIDs, steroids, or anticoagulants affecting healing.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• Asian Institute of Gastroenterology /Aig Hospitals — Hyderabad

Идентификаторы

NCT: NCT06953986 · VNP2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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