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

NCT06526455 | Not Yet Recruiting Phase 4

• 1 other identifier: PJKT2024-109
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 4

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. 1.Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers?
2. 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.

Conditions

Ulcers, Gastric

Outcome Measures

Primary Outcomes (1)

• Rate of ulcer reduction

  Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100% Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100%

  2nd and 8th week post-dose

Secondary Outcomes (6)

• Size of ulcer

  2nd and 8th week post-dose

• Rate of ulcer healing

  2nd and 8th week post-dose

• Rate of bumpy

  2nd and 8th week post-dose

• Quality of ulcer healing

  2nd and 8th week post-dose

• Rate of delayed hemorrhage

  2th week post-dose

Study Arms (2)

Treatment group

EXPERIMENTAL

Vonorasan、tablet、20mg、qd、Days 3 to 56

Drug: Vonoprazan

Control group

ACTIVE COMPARATOR

Esomeprazole 、tablet、20mg、Days 3 to 56

Drug: Esomeprazole

Interventions

Vonoprazan DRUG

oral drug 3-56 days after ESD.

Treatment group

Esomeprazole DRUG

oral drug 3-56 days after ESD.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets surgical indications for ESD
• Age 18-70 years, regardless of gender
• Normal coagulation
• ESD Postoperative ulcers ≤3cm
• Voluntary participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Shicai Ye: lead
• First Affiliated Hospital of Jinan University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Maoming People's Hospital: collaborator
• Yellow River Sanmenxia hospital: collaborator

Study Sites (4)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

The First Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Maoming People's Hospital

Maoming, Guangdong, China

Location

Yellow River Sanmenxia Hospital

Sanmenxia, Henan, China

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Esomeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Shicai Ye, PhD

CONTACT

+86 133 6070 9925; caizi23@126.com

Yuping Yang, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (4)