Ulcers, GastricPhase 4NCT06526455
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
A Phase 4 study testing Vonoprazan and Esomeprazole in people with Ulcers, Gastric, run by Shicai Ye at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcers, Gastric
- What is being tested?
- Vonoprazan and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 5 sitesChina
- Study dates
- 2 Dec 2024to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets surgical indications for ESD
- Age 18-70 years, regardless of gender
- Normal coagulation
- ESD Postoperative ulcers ≤3cm
- Voluntary participation in the study
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yuping Yang, PhD contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Biao Nie, PhD, 18927536167, niebiao2@163.com
- Recruiting
The First Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Kequan Chen, PhD, 13580510159, yinyuedegushi@126.com
- Recruiting
Maoming People's Hospital
Maoming, Guangdong
Quanxiang Zeng, master's degree, 13553660612, 297938513@qq.com
- Recruiting
Yellow River Sanmenxia Hospital
Sanmenxia, Henan
Shenshen Du, PhD, 18999328747, dushenshen2021@163.com
- Recruiting
Affiliated Hospital of Guangdong Medical University广东医科大...
Zhanjiang, Guangdong, 524000
Yu ping Yang, Doctor of Medicine, 13535067921, yangyupingchn@163.com
About this study
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
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:
- Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers?
- 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.
Read more
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.
- Conditions
- Ulcers, Gastric
- Being tested
- Vonoprazan, Esomeprazole
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
oral drug 3-56 days after ESD.
EsomeprazoleDrug
oral drug 3-56 days after ESD.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Vonorasan、tablet、20mg、qd、Days 3 to 56 Receives: Drug: Vonoprazan |
| Control group | Active comparator | Esomeprazole 、tablet、20mg、Days 3 to 56 Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 2nd and 8th week post-dose
Secondary outcomes (6)
Size of ulcer
Ulcer area = maximum diameter of the ulcer * perpendicular line of the maximum diameter (mm2)
Measured: 2nd and 8th week post-dose
Rate of ulcer healing
Healing rate = number of cases with scarring/total number of cases × 100 per cent
Measured: 2nd and 8th week post-dose
Rate of bumpy
Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent
Measured: 2nd and 8th week post-dose
Quality of ulcer healing
Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing
Measured: 2nd and 8th week post-dose
Rate of delayed hemorrhage
Rate of delayed hemorrhage=Number of haemorrhages/total
Measured: 2th week post-dose
Postoperative symptom relief rate
Number of persons in remission/total
Measured: 2th week post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start2 Dec 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcers, GastricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shicai Ye
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University, The First Affiliated Hospital of Guangzhou Medical University, Maoming People's Hospital, Yellow River Sanmenxia hospital
- Responsible party
- Sponsor-investigator, Shicai Ye, Affiliated Hospital of Guangdong Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526455
- Sponsor's protocol ID
- PJKT2024-109
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06526455
- Acronym / sponsor ID
- PJKT2024-109
- Conditions
- Ulcers, Gastric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Shicai YeUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University, The First Affiliated Hospital of Guangzhou Medical University, Maoming People's Hospital, Yellow River Sanmenxia hospital
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: VonoprazanVonorasan、tablet、20mg、qd、Days 3 to 56 |
| Control group | Active comparator | Drug: EsomeprazoleEsomeprazole 、tablet、20mg、Days 3 to 56 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets surgical indications for ESD
- Age 18-70 years, regardless of gender
- Normal coagulation
- ESD Postoperative ulcers ≤3cm
- Voluntary participation in the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vonoprazanoral drug 3-56 days after ESD. | Drug | Treatment group |
| Esomeprazoleoral drug 3-56 days after ESD. | Drug | Control group |
Primary outcome
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%
6 secondary outcomes
Size of ulcer
Time frame: 2nd and 8th week post-dose
Rate of ulcer healing
Time frame: 2nd and 8th week post-dose
Rate of bumpy
Time frame: 2nd and 8th week post-dose
Quality of ulcer healing
Time frame: 2nd and 8th week post-dose
Rate of delayed hemorrhage
Time frame: 2th week post-dose
Postoperative symptom relief rate
Time frame: 2th week post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuping Yang, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan and Esomeprazole in people with Ulcers, Gastric, run by Shicai Ye at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shicai Ye, PhD (+86 133 6070 9925, caizi23@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ulcer reduction (time frame: 2nd and 8th week post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.