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ClinicalTrials.gov ID

NCT06526455

Lead Sponsor

Shicai YeOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

196Estimated

Last Update Posted

Jul 29, 2024Actual

Start Date

Aug 1, 2024Estimated

Primary Completion Date

Jun 30, 2029Estimated

Completion Date

Jun 30, 2029Estimated

Official Title

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

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 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.

• Ulcers, Gastric

• Vonoprazan
• Esomeprazole

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Shicai YeOTHER

Collaborators

First Affiliated Hospital of Jinan UniversityOTHER

The First Affiliated Hospital of Guangzhou Medical UniversityOTHER

Maoming People's HospitalOTHER

Yellow River Sanmenxia hospitalUNKNOWN

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