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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Rate of ulcer reduction
研究概览
简要总结
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:
- Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets surgical indications for ESD
- •Age 18-70 years, regardless of gender
- •Normal coagulation
- •ESD Postoperative ulcers ≤3cm
- •Voluntary participation in the study
排除标准
- •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
研究组 & 干预措施
Treatment group
Vonorasan、tablet、20mg、qd、Days 3 to 56
干预措施: Vonoprazan (Drug)
Control group
Esomeprazole 、tablet、20mg、Days 3 to 56
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Rate of ulcer reduction
时间窗: 2nd and 8th week post-dose
Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100% Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100%
次要结局
- Rate of ulcer healing(2nd and 8th week post-dose)
- Size of ulcer(2nd and 8th week post-dose)
- Postoperative symptom relief rate(2th week post-dose)
- Rate of bumpy(2nd and 8th week post-dose)
- Rate of delayed hemorrhage(2th week post-dose)
- Quality of ulcer healing(2nd and 8th week post-dose)
研究者
Shicai Ye
chief physician
Affiliated Hospital of Guangdong Medical University