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
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.
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)
Parallel
Vonorasan fumarate injection1
Drug40 mg (20 mg bid, 6 hours apart, Day1) + 20 mg (Day2\&3, q24h), ivd, 30 min, administered for 3 days
Vonorasan fumarate injection2
Drug40mg（Day1）+20mg（Day 2\&3），ivd，30min，q24h，administered for 3 days
Esomeprazole sodium for injection
Drug80mg，iv，30±3min； Followed by 8 mg/h, ivd, 71.5 h
The rebleeding rate within 72 hours after the initiation of medication evaluated by endoscopy.
The rebleeding rate within 72 hours and 120 hours after the initiation of medication clinical evaluation.
The transfusion rate and average transfusion volume of subjects due to bleeding within 72 hours and 120 hours after the initiation of medication;
The proportion of subjects who required re-endoscopic hemostatic treatment due to bleeding within 72 hours and 120 hours after the initiation of medication.
The proportion of subjects who required surgical treatment due to bleeding within 72 hours and 120 hours after the initiation of medication.
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This trial is not recruiting at the moment. You can still explore other options:
