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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcers, Gastric
• Intervention / Treatment: Drug: Vonoprazan; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shicai Ye, PhD; Phone Number: +86 133 6070 9925; Email: caizi23@126.com
• Study Contact Backup: Name: Yuping Yang, PhD

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
      • Contact: Biao Nie, PhD; Phone Number: 18927536167; Email: niebiao2@163.com
    • Guangzhou, Guangdong, China
      • The First Hospital of Guangzhou Medical University
      • Contact: Kequan Chen, PhD; Phone Number: 13580510159; Email: yinyuedegushi@126.com
    • Maoming, Guangdong, China
      • Maoming People's Hospital
  • Henan
    • Sanmenxia, Henan, China
      • Yellow River Sanmenxia Hospital
      • Contact: Shenshen Du, PhD; Phone Number: 18999328747; Email: dushenshen2021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Vonorasan、tablet、20mg、qd、Days 3 to 56	Drug: Vonoprazan; oral drug 3-56 days after ESD.
Active Comparator: Control group; Esomeprazole 、tablet、20mg、Days 3 to 56	Drug: Esomeprazole; oral drug 3-56 days after ESD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ulcer reduction	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%	2nd and 8th week post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of ulcer	Ulcer area = maximum diameter of the ulcer * perpendicular line of the maximum diameter (mm2)	2nd and 8th week post-dose
Rate of ulcer healing	Healing rate = number of cases with scarring/total number of cases × 100 per cent	2nd and 8th week post-dose
Rate of bumpy	Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent	2nd and 8th week post-dose
Quality of ulcer healing	Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing	2nd and 8th week post-dose
Rate of delayed hemorrhage	Rate of delayed hemorrhage=Number of haemorrhages/total	2th week post-dose
Postoperative symptom relief rate	Number of persons in remission/total	2th week post-dose

Collaborators and Investigators

• Sponsor: Shicai Ye
• Collaborators: The First Affiliated Hospital of Guangzhou Medical University; First Affiliated Hospital of Jinan University; Maoming People's Hospital; Yellow River Sanmenxia hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Stomach Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: PJKT2024-109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No