Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection

Официальное название

Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection (ESD): a Multicentre, Parallel-design, Double-blind, Randomised Controlled Study

Обзор

The purpose of this clinical trial is to find out the effectiveness of voronasan in combination with aluminum phosphate gel in the treatment of post-operative ESD ulcers. It will also find out about the safety of vunorasan in combination with aluminum phosphate gel. The main questions it aims to answer are: 1. Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers? 2. What medical problems do participants have when taking drug vonorasan in combination with aluminum phosphate gel? Researchers compared the drug voransen in combination with aluminum phosphate gel to esomeprazole in combination with aluminum phosphate gel to see if voransen in combination with aluminum phosphate gel worked better for post-operative ESD ulcers. Participants will: Intravenous lansoprazole 1-3 days after ESD and oral voronasan combined with aluminum phosphate gel or esomeprazole combined with aluminum phosphate gel 3-56 days after ESD. Record their symptoms, endoscopic ulcer grading, ulcer size and Calculate ulcer healing rate at weeks 2 and 8.

Вмешательства

• Препарат Vonoprazan
  oral drug 3-56 days after ESD.
• Препарат Esomeprazole
  oral drug 3-56 days after ESD.

Первичные конечные точки

• Rate of ulcer reduction [Срок оценки: 2nd and 8th week post-dose]

Вторичные конечные точки (6)

• Size of ulcer [Срок оценки: 2nd and 8th week post-dose]
• Rate of ulcer healing [Срок оценки: 2nd and 8th week post-dose]
• Rate of bumpy [Срок оценки: 2nd and 8th week post-dose]
• Quality of ulcer healing [Срок оценки: 2nd and 8th week post-dose]
• Rate of delayed hemorrhage [Срок оценки: 2th week post-dose]
• Postoperative symptom relief rate [Срок оценки: 2th week post-dose]

Критерии участия

Критерии включения

• Meets surgical indications for ESD
• Age 18-70 years, regardless of gender
• Normal coagulation
• ESD Postoperative ulcers ≤3cm
• Voluntary participation in the study

Критерии исключения

• Patients with severe complications or failure to achieve curative resection after gastric ESD surgery need supplementary surgery
• Women who are pregnant or breastfeeding, or who may conceive during clinical trials
• The patient has other serious organic diseases that affect the evaluation of the study, such as severe liver disease, heart disease, renal disease, malignant neoplasm and alcoholism
• Patients who need to take antiplatelet and NSAIDS drugs for a long period of time
• Co-administration of unspecified anti-ulcer drugs during the trial period;Allergic reactions to vornoxan, aluminium phosphate gel or esomeprazole
• Patients with no capacity for autonomous behaviors, unable to correctly express their main complaint, such as those with mental illness, severe neurosis, and unable to cooperate with this experiment
• ESD Postoperative ulcers >3cm

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• The First Affiliated Hospital of Jinan University — Гуанчжоу
• The First Hospital of Guangzhou Medical University — Гуанчжоу
• Maoming People's Hospital — Maoming
• Yellow River Sanmenxia Hospital — Sanmenxia

Идентификаторы

NCT: NCT06526455 · PJKT2024-109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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