Assisted eradication of Helicobacter Pylori
Conditions
Interventions
experimental group 1:H009 injection low-dose group
experimental group 2:H009 injection high-dose group
control group :Esomeprazole sodium for injection
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.18 years= age = 70years, regardless of gender; 2. Symptoms of upper gastrointestinal bleeding, such as hematemesis, melena or other possible clinical manifestations within 48 hours before screening; 3. If the upper gastrointestinal bleeding caused by gastric and/or duodenal ulcer is confirmed by endoscopy within 24 hours before randomization, the maximum diameter of the ulcer is 3-20mm; 4. The Forrest grade of peptic ulcer is ? a, ? b, ? a, ? b, and multiple ulcers are judged according to the higher Forrest grade. For those confirmed to have successfully stopped bleeding after endoscopic treatment, the endoscopic treatment requirements are as follows: Forrest Ia, Ib, ? a: thermal coagulation or mechanical hemostasis is used as the main means. It is also allowed to combine local adrenaline drug injection on the basis of the above main means; Forrest IIb: the attached blood clot shall be removed by endoscopic flushing. After the blood clot is cleared, Forrest grade shall be evaluated again. If the blood clot is Forrest Ia, Ib, IIa, endoscopic hemostasis shall be performed according to the above requirements. If it is still Forrest IIb, it is allowed to be directly included in the group; 5. Fully understand the test content, voluntarily participate in the test, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known to have a history of allergy to vorolaxone, Esomeprazole, other benzimidazole compounds or any other component of the study drug; 2. Hemorrhagic shock or unsuccessful endoscopic treatment requiring arterial catheter embolization or surgical treatment; 3. Accompanied with upper gastrointestinal bleeding caused by other reasons or suspected to be gastric malignant tumor under endoscopy; 4. Those who have undergone gastrectomy and gastrointestinal anastomosis; 5. Coagulation dysfunction (platelet 1.5 times of upper limit of normal value, Cr > upper limit of normal value); 7. The subject is accompanied by other serious diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, and the investigator believes that the research results may be confused or the safety of the subject may be affected; 8. Patients with a history of malignant tumor within 5 years before screening (if the skin basal cell carcinoma or cervical carcinoma in situ of the subject has been cured, he/she can participate in this study); 9. Intravenous use of proton pump inhibitors (PPIs) exceeds the standard dose of single intravenous administration of PPIs within 24 hours before screening; 10. During the trial, it may be necessary to use drugs that interfere with the judgment of disease efficacy, including somatostatin; Acid inhibitors (histamine-2 receptor antagonist H2RAs): ranitidine, famotidine, other PPI or potassium competitive acid blockers (P-CAB): omeprazole, rabeprazole, pantoprazole, vorolazon, etc.); Gastrointestinal mucosal protective agents (such as sucralfate tablets); Anticoagulants (such as heparin, warfarin, vitamin K antagonist, etc.); Antiplatelet drugs (aspirin, clopidogrel, etc.); Hemostatic drugs (such as hemostatic aromatic acid, hemostatic drug, reptilase, Yunnan Baiyao and thrombin); Glucocorticoid; Non steroidal anti-inflammatory drugs; 11. Patients who were using azanavir sulfate, nefenavir and saquinavir at the time of screening; 12. Female subjects who suspect or have been pregnant, lactating or preparing for pregnancy during the trial. According to the judgment of the researcher, women of childbearing age who could not take reliable contraception methods recognized by medical science within 4 weeks after signing the informed consent form and the last administration of the study; 13. Those who have participated in clinical studies of other drugs/devices and used experimental drugs/devices within 3 months before randomization; 14. Other situations that the investigator thinks the subject should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of no rebleeding within 72h after initiation of administration (endoscopic evaluation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of no rebleeding within 72h after initiation of administration (clinical evaluation);Blood transfusion rate and mean volume of blood transfusions due to bleeding within 72 hours after initiation of medication;Proportion of subjects requiring retreatment with endoscopic hemostasis due to bleeding within 72 hours of drug initiation;Proportion of patients requiring surgical treatment for bleeding within 72 hours of drug initiation;Mortality rate within 72 hours after initiation of dosing; | — |
Countries
China
Contacts
Public ContactMinhu Chen, Yinglian Xiao
Nanjing Carephar shenghui Pharmaceutical Co., Ltd.
Outcome results
None listed