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NOT YET RECRUITING
NCT06526455
PHASE4

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

Sponsor: Shicai Ye

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2024-08-01

Completion Date

2029-06-30

Last Updated

2024-07-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

Vonoprazan

oral drug 3-56 days after ESD.

DRUG

Esomeprazole

oral drug 3-56 days after ESD.

Locations (4)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

The First Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Maoming People's Hospital

Maoming, Guangdong, China

Yellow River Sanmenxia Hospital

Sanmenxia, Henan, China