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Not yet recruiting NCT06526455

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

Phase IV Interventional Ulcers, Gastric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vonoprazan, Esomeprazole.
Who it may be relevant to
Registry conditions: Ulcers, Gastric. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug Vonoprazan
    oral drug 3-56 days after ESD.
  • Drug Esomeprazole
    oral drug 3-56 days after ESD.

Primary outcome measures

  • Rate of ulcer reduction [Time frame: 2nd and 8th week post-dose]
Secondary outcome measures (6)
  • Size of ulcer [Time frame: 2nd and 8th week post-dose]
  • Rate of ulcer healing [Time frame: 2nd and 8th week post-dose]
  • Rate of bumpy [Time frame: 2nd and 8th week post-dose]
  • Quality of ulcer healing [Time frame: 2nd and 8th week post-dose]
  • Rate of delayed hemorrhage [Time frame: 2th week post-dose]
  • Postoperative symptom relief rate [Time frame: 2th week post-dose]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 4 centers
  • The First Affiliated Hospital of Jinan University — Guangzhou
  • The First Hospital of Guangzhou Medical University — Guangzhou
  • Maoming People's Hospital — Maoming
  • Yellow River Sanmenxia Hospital — Sanmenxia

Identifiers

NCT: NCT06526455 · PJKT2024-109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗