Voronasan with aluminum phosphate gel vs esomeprazole after gastric ESD ulcers
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
Run by Affiliated Hospital of Guangdong Medical University · NCT06526455 · Data updated 2026-11-12
This study tests whether voronasan with aluminum phosphate gel can heal post-ESD gastric ulcers better than esomeprazole with aluminum phosphate gel.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Affiliated Hospital of Guangdong Medical University Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06526455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-70 who have undergone gastric ESD with ulcers ≤3 cm and meet normal coagulation criteria.
✕Probably not a fit
Patients with severe comorbidity, ongoing NSAID or anti-ulcer co-therapy, or those unable to adhere to the regimen may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional trial compares voronasan plus aluminum phosphate gel to esomeprazole plus aluminum phosphate gel for the treatment of ulcers that form after endoscopic submucosal dissection in adults. Participants receive intravenous lansoprazole 1-3 days after ESD, followed by either oral voronasan with aluminum phosphate gel or esomeprazole with aluminum phosphate gel for 3-56 days. The study aims to determine the clinical effectiveness and safety of voronasan in this combination and to describe any medical issues that arise during treatment. Eligibility includes adults 18-70 with postoperative ulcers ≤3 cm and adequate coagulation; key exclusions include pregnancy, significant comorbidity, and concurrent anti-ulcer or NSAID use.
Why it matters
Potential benefit: If successful, patients may experience faster healing of post-ESD ulcers and improved symptom control with voronasan-based therapy.
How similar studies have gone: Prior studies in similar ulcer-healing regimens have shown variable success; this trial investigates a novel combination involving voronasan.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China Recruiting -
The First Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting -
Maoming People's Hospital
Maoming, Guangdong, China Recruiting -
Affiliated Hospital of Guangdong Medical University广东医科大...
Zhanjiang, Guangdong, China Recruiting -
Yellow River Sanmenxia Hospital
Sanmenxia, Henan, China Recruiting
Study contacts
- Study coordinator: Shicai Ye, PhD
- Email: caizi23@126.com
- Phone: +86 133 6070 9925
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.