Peptic Ulcer BleedingPhase 2NCT06783257
Phase II Clinical Study of Vonorasan Fumarate Injection in the Treatment of Peptic Ulcer Bleeding
A Phase 2 study testing Vonorasan fumarate injection1, Vonorasan fumarate injection2 and Esomeprazole sodium for injection in people with Peptic Ulcer Bleeding, run by Shandong New Time Pharmaceutical Co., LTD.
Trial summary
A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peptic Ulcer Bleeding
- What is being tested?
- Vonorasan fumarate injection1, Vonorasan fumarate injection2 and Esomeprazole sodium for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2027
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign the informed consent form.
- Individuals aged between 18 and 75 years, regardless of gender.
- Clinical manifestations of upper gastrointestinal bleeding, such as hematemesis, melena, or positive fecal occult blood, within 48 hours prior to screening.
- Patients diagnosed with upper gastrointestinal bleeding caused by gastric and/or duodenal ulcers through endoscopic examination within 24 hours prior to random group selection, with ulcer maximum diameter ranging from 3 to 20 mm.
- The classification of peptic ulcers according to Forrest is as follows: Ia, Ib, IIa, IIb. For multiple ulcers, the higher Forrest grade is used for determination. After confirming the ability to achieve hemostasis through endoscopic treatment, the following requirements for endoscopic treatment are as follows:
- For Forrest Ia, Ib, IIa: Thermal hemostasis or mechanical hemostasis is the primary method, and it is also permissible to combine local epinephrine injection based on the aforementioned primary methods;
- For Forrest IIb: To confirm the specific grade, endoscopic irrigation to remove attached blood clots should be attempted first. If the blood clots are cleared, the Forrest grade should be reassessed. If it is classified as Forrest Ia, Ib, or IIa, endoscopic hemostatic treatment should be performed as per the above requirements. If the blood clots are not cleared and it is ultimately confirmed as Forrest IIb, direct grouping is permitted.
Who cannot join
- Individuals with a clinically significant history of drug allergies or known allergies to the components and excipients of the study drug;
- Subjects with other severe central nervous system, cardiovascular, respiratory, organ, renal, gastrointestinal, urinary, endocrine, or hematological diseases, which the investigator believes may confound the study results or affect the safety of the subjects;
- Hematological disorders: ① Platelet count <80×10^9/L; ② PT exceeds the upper limit of normal by 3 seconds; ③ APTT exceeds the upper limit of normal by 10 seconds; (If any of these criteria are met, the patient is not eligible for selection)
- Renal function abnormalities: ① ALT or AST ≥1.5×ULN; ② Total bilirubin >1.5×ULN; ③ Serum creatinine (Cr) > ULN; (If any of these criteria are met, the patient is not eligible for selection)
- A history of drug abuse within the last 5 years;
- Receipt of live vaccines or attenuated live vaccines within 30 days prior to the first administration, or plans to receive vaccinations during the study period;
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- Hemorrhagic shock (occurring during the screening period with systolic blood pressure <90 mmHg and heart rate >120 beats/min, accompanied by symptoms such as pallor, cold and clammy extremities, restlessness, or altered mental status) or requiring arterial catheter embolization or surgical intervention due to unsuccessful endoscopic treatment;
- Concurrent upper gastrointestinal bleeding from other causes or suspected gastric malignancy under endoscopy; There is a clear history of surgery to reduce gastric acid or a history of gastric surgery (including but not limited to partial gastrectomy, gastric plasty, vagotomy, excluding simple perforation suturing);
- 10. A history of malignant tumors within 5 years prior to screening (if the subject has been cured of skin basal cell carcinoma or cervical carcinoma in situ, he/she may participate in this study); 11. Use of proton pump inhibitors (PPIs) or H2 receptor antagonists or P-CAB preparations exceeding a single dose of the standard dose within 24 hours prior to screening, or having undergone endoscopic treatment/intervention before signing the informed consent form, and having used PPIs, P-CAB preparations, H2 receptor antagonists, somatostatin, or hemostatic agents after endoscopic treatment/intervention until the selection for this study; 12. Patients currently using drugs with a clear risk of interaction with the investigational drug, such as azanavir sulfate, nelfinavir, saquinavir, or liponavir; 13. Use of hemostatic powder Endoclot AHP® or other local hemostatic agents during endoscopy that, in the investigator's judgment, affect the efficacy of the investigational drug; 14. Pregnant or breastfeeding women, as well as those with plans for pregnancy or sperm/egg donation within 3 months after the end of the study, who are unwilling to adopt a medically recognized contraceptive method (such as an intrauterine device or condom) during the study; 15. Participation in other drug/device clinical studies and use of investigational drugs/devices within 3 months prior to randomization; 16. Other subjects deemed unsuitable for selection by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding
A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding
Read the detailed description
The trial was divided into screening period, treatment period and follow-up period.Subjects who did not meet the exclusion criteria were randomly assigned to vonorasan fumarate injection or esoprazole sodium for injection for 3 days; Safety was followed up to 2 days after the end of intravenous administration.
- Conditions
- Peptic Ulcer Bleeding
- Being tested
- Vonorasan fumarate injection1, Vonorasan fumarate injection2, Esomeprazole sodium for injection
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonorasan fumarate injection1Drug
40 mg (20 mg bid, 6 hours apart, Day1) + 20 mg (Day2\&3, q24h), ivd, 30 min, administered for 3 days
Vonorasan fumarate injection2Drug
40mg（Day1）+20mg（Day 2\&3），ivd，30min，q24h，administered for 3 days
Esomeprazole sodium for injectionDrug
80mg，iv，30±3min； Followed by 8 mg/h, ivd, 71.5 h
| Study group | Role | What they receive |
|---|---|---|
| Vonora fumarate Injections 1 | Experimental | 40 mg (20 mg bid, 6 hours apart, Day1) + 20 mg (Day2\&3, q24h), ivd, 30 min, administered for 3 days Receives: Drug: Vonorasan fumarate injection1 |
| Vonora fumarate Injections 2 | Experimental | 40mg（Day1）+20mg（Day 2\&3），ivd，30min，q24h，administered for 3 days Receives: Drug: Vonorasan fumarate injection2 |
| Esomeprazole sodium for injection | Active comparator | 80mg，iv，30±3min； Followed by 8 mg/h, ivd, 71.5 h Receives: Drug: Esomeprazole sodium for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rebleeding rate within 72 hours after the initiation of medication evaluated by endoscopy.
Measured: 72 hours
Secondary outcomes (6)
The rebleeding rate within 72 hours and 120 hours after the initiation of medication clinical evaluation.
Measured: 72 hours, 120 hours
The transfusion rate and average transfusion volume of subjects due to bleeding within 72 hours and 120 hours after the initiation of medication;
Measured: 72 hours, 120 hours
The proportion of subjects who required re-endoscopic hemostatic treatment due to bleeding within 72 hours and 120 hours after the initiation of medication.
Measured: 72 hours, 120 hours
The proportion of subjects who required surgical treatment due to bleeding within 72 hours and 120 hours after the initiation of medication.
Measured: 72 hours, 120 hours
The mortality rate of subjects within 72 hours and 120 hours after the initiation of medication.
Measured: 72 hours, 120 hours
The incidence ofadverse reactions
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer BleedingStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783257
- Sponsor's protocol ID
- NTP-FNLS-004
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT06783257
- Acronym / sponsor ID
- NTP-FNLS-004
- Conditions
- Peptic Ulcer Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding
Detailed description
The trial was divided into screening period, treatment period and follow-up period.Subjects who did not meet the exclusion criteria were randomly assigned to vonorasan fumarate injection or esoprazole sodium for injection for 3 days; Safety was followed up to 2 days after the end of intravenous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vonora fumarate Injections 1 | Experimental | Drug: Vonorasan fumarate injection140 mg (20 mg bid, 6 hours apart, Day1) + 20 mg (Day2\&3, q24h), ivd, 30 min, administered for 3 days |
| Vonora fumarate Injections 2 | Experimental | Drug: Vonorasan fumarate injection240mg（Day1）+20mg（Day 2\&3），ivd，30min，q24h，administered for 3 days |
| Esomeprazole sodium for injection | Active comparator | Drug: Esomeprazole sodium for injection80mg，iv，30±3min； Followed by 8 mg/h, ivd, 71.5 h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate and sign the informed consent form.
- Individuals aged between 18 and 75 years, regardless of gender.
- Clinical manifestations of upper gastrointestinal bleeding, such as hematemesis, melena, or positive fecal occult blood, within 48 hours prior to screening.
- Patients diagnosed with upper gastrointestinal bleeding caused by gastric and/or duodenal ulcers through endoscopic examination within 24 hours prior to random group selection, with ulcer maximum diameter ranging from 3 to 20 mm.
- The classification of peptic ulcers according to Forrest is as follows: Ia, Ib, IIa, IIb. For multiple ulcers, the higher Forrest grade is used for determination. After confirming the ability to achieve hemostasis through endoscopic treatment, the following requirements for endoscopic treatment are as follows:
Key exclusion criteria (9 listed)
- Individuals with a clinically significant history of drug allergies or known allergies to the components and excipients of the study drug;
- Subjects with other severe central nervous system, cardiovascular, respiratory, organ, renal, gastrointestinal, urinary, endocrine, or hematological diseases, which the investigator believes may confound the study results or affect the safety of the subjects;
- Hematological disorders: ① Platelet count <80×10^9/L; ② PT exceeds the upper limit of normal by 3 seconds; ③ APTT exceeds the upper limit of normal by 10 seconds; (If any of these criteria are met, the patient is not eligible for selection)
- Renal function abnormalities: ① ALT or AST ≥1.5×ULN; ② Total bilirubin >1.5×ULN; ③ Serum creatinine (Cr) > ULN; (If any of these criteria are met, the patient is not eligible for selection)
- A history of drug abuse within the last 5 years;
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 |
|---|---|---|
| Vonorasan fumarate injection140 mg (20 mg bid, 6 hours apart, Day1) + 20 mg (Day2\&3, q24h), ivd, 30 min, administered for 3 days | Drug | Vonora fumarate Injections 1 |
| Vonorasan fumarate injection240mg（Day1）+20mg（Day 2\&3），ivd，30min，q24h，administered for 3 days | Drug | Vonora fumarate Injections 2 |
| Esomeprazole sodium for injection80mg，iv，30±3min； Followed by 8 mg/h, ivd, 71.5 h | Drug | Esomeprazole sodium for injection |
Primary outcome
The rebleeding rate within 72 hours after the initiation of medication evaluated by endoscopy.
Time frame: 72 hours
6 secondary outcomes
The rebleeding rate within 72 hours and 120 hours after the initiation of medication clinical evaluation.
Time frame: 72 hours, 120 hours
The transfusion rate and average transfusion volume of subjects due to bleeding within 72 hours and 120 hours after the initiation of medication;
Time frame: 72 hours, 120 hours
The proportion of subjects who required re-endoscopic hemostatic treatment due to bleeding within 72 hours and 120 hours after the initiation of medication.
Time frame: 72 hours, 120 hours
The proportion of subjects who required surgical treatment due to bleeding within 72 hours and 120 hours after the initiation of medication.
Time frame: 72 hours, 120 hours
The mortality rate of subjects within 72 hours and 120 hours after the initiation of medication.
Time frame: 72 hours, 120 hours
The incidence ofadverse reactions
Time frame: 120 hours
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 20 Jan 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vonorasan fumarate injection1, Vonorasan fumarate injection2 and Esomeprazole sodium for injection in people with Peptic Ulcer Bleeding, run by Shandong New Time Pharmaceutical Co., LTD.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yang (13911876975, yanghui1234359@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rebleeding rate within 72 hours after the initiation of medication evaluated by endoscopy. (time frame: 72 hours). 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 20 Jan 2025.