Clinical trial NCT06526455: Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ulcers, Gastric
Lead sponsor: Affiliated Hospital of Guangdong Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Jinan University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Maoming People's Hospital
name: Yellow River Sanmenxia hospital
First posted: 2024-07-29
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Rate of ulcer reduction
timeFrame: 2nd and 8th week post-dose
Secondary outcomes:
measure: Size of ulcer
timeFrame: 2nd and 8th week post-dose
measure: Rate of ulcer healing
timeFrame: 2nd and 8th week post-dose
measure: Rate of bumpy
timeFrame: 2nd and 8th week post-dose
measure: Quality of ulcer healing
timeFrame: 2nd and 8th week post-dose
measure: Rate of delayed hemorrhage
timeFrame: 2th week post-dose
measure: Postoperative symptom relief rate
timeFrame: 2th week post-dose
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The First Hospital of Guangzhou Medical University
state: Guangdong
city: Maoming
country: China
facility: Maoming People's Hospital
state: Guangdong
city: Sanmenxia
country: China
facility: Yellow River Sanmenxia Hospital
state: Henan
Study officials:
References: