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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086012
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric endoscopic submucosal dissection-induced ulcer

Interventions

Treatment group:Vonorasan + aluminium phosphate gel
Control group:Esomeprazole + aluminium phosphate gel

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meets surgical indications for ESD; 2. Age 18-70 years, regardless of gender; 3. Normal coagulation; 4. ESD Postoperative ulcers =3cm; 5. Voluntary participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe complications or failure to achieve curative resection after gastric ESD surgery need supplementary surgery; 2. Women who are pregnant or breastfeeding, or who may conceive during clinical trials; 3. 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; 4. Patients who need to take antiplatelet and NSAIDS drugs for a long period of time; 5. Co-administration of unspecified anti-ulcer drugs during the trial period; 6. Allergic reactions to vornoxan, aluminium phosphate gel or esomeprazole; 7. 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 8. ESD Postoperative ulcers >3cm.

Design outcomes

Primary

MeasureTime frame
Rate of ulcer reduction;

Secondary

MeasureTime frame
Size of ulcer;Rate of ulcer healing;Incidence of wart-like projections;Quality of ulcer healing;Incidence of delayed hemorrhage;Postoperative symptom relief rate;

Countries

China

Contacts

Public ContactYe Shicai /Yang Yuping

Affiliated Hospital of Guangdong Medical University

caizi23@126.com+86 133 6070 9925

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026