Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
NCT ID: NCT06526455
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
196 participants
INTERVENTIONAL
2024-08-01
2029-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group
Vonorasan、tablet、20mg、qd、Days 3 to 56
Vonoprazan
oral drug 3-56 days after ESD.
Control group
Esomeprazole 、tablet、20mg、Days 3 to 56
Esomeprazole
oral drug 3-56 days after ESD.
Interventions
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Vonoprazan
oral drug 3-56 days after ESD.
Esomeprazole
oral drug 3-56 days after ESD.
Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years, regardless of gender
* Normal coagulation
* ESD Postoperative ulcers ≤3cm
* Voluntary participation in the study
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital of Jinan University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Maoming People's Hospital
OTHER
Yellow River Sanmenxia hospital
UNKNOWN
Shicai Ye
OTHER
Responsible Party
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Shicai Ye
chief physician
Locations
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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
Countries
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Central Contacts
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Yuping Yang, PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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PJKT2024-109
Identifier Type: -
Identifier Source: org_study_id
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