Status:
NOT_YET_RECRUITING
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Lead Sponsor:
Shicai Ye
Collaborating Sponsors:
First Affiliated Hospital of Jinan University
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Ulcers, Gastric
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Meets surgical indications for ESD
- Age 18-70 years, regardless of gender
- Normal coagulation
- ESD Postoperative ulcers ≤3cm
- Voluntary participation in the study
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06526455
Start Date
August 1 2024
End Date
June 30 2029
Last Update
July 29 2024
Active Locations (4)
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1
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
2
The First Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
3
Maoming People's Hospital
Maoming, Guangdong, China
4
Yellow River Sanmenxia Hospital
Sanmenxia, Henan, China