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

Shicai Ye

Status and phase: Not yet enrolling; Phase 4

Conditions: Ulcers, Gastric

Treatments: Drug: Esomeprazole; Drug: Vonoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT06526455

PJKT2024-109

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups

Treatment group

Experimental group

Description:

Vonorasan、tablet、20mg、qd、Days 3 to 56

Treatment:

Drug: Vonoprazan

Control group

Active Comparator group

Description:

Esomeprazole 、tablet、20mg、Days 3 to 56

Treatment:

Drug: Esomeprazole