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NCT Number: NCT06526455

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

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.

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Key information

Conditions

Ulcers, Gastric Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vonoprazan

Drug

oral drug 3-56 days after ESD.

Esomeprazole

Drug

oral drug 3-56 days after ESD.

Primary outcomes

  1. Rate of ulcer reduction

    Time frame: 2nd and 8th week post-dose

    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%

Secondary outcomes

  1. Size of ulcer

    Time frame: 2nd and 8th week post-dose

    Ulcer area = maximum diameter of the ulcer * perpendicular line of the maximum diameter (mm2)

  2. Rate of ulcer healing

    Time frame: 2nd and 8th week post-dose

    Healing rate = number of cases with scarring/total number of cases × 100 per cent

  3. Rate of bumpy

    Time frame: 2nd and 8th week post-dose

    Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent

  4. Quality of ulcer healing

    Time frame: 2nd and 8th week post-dose

    Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing

  5. Rate of delayed hemorrhage

    Time frame: 2th week post-dose

    Rate of delayed hemorrhage=Number of haemorrhages/total

  6. Postoperative symptom relief rate

    Time frame: 2th week post-dose

    Number of persons in remission/total

Study contacts

Contact information is provided by the study sponsor or research team.

Shicai Ye, PhD

CONTACT

[email protected]

+86 133 6070 9925

Yuping Yang, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Shicai Ye

Other

Collaborators

  • First Affiliated Hospital of Jinan University
  • Maoming People's Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • Yellow River Sanmenxia hospital

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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