Not Yet RecruitingPhase 2

Phase II Clinical Study of Vonorasan Fumarate Injection in the Treatment of Peptic Ulcer Bleeding

150 participantsStarted 2025-02

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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;
✕. 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);

What they're measuring

The rebleeding rate within 72 hours after the initiation of medication evaluated by endoscopy.

Timeframe: 72 hours

Trial details

NCT IDNCT06783257

SponsorShandong New Time Pharmaceutical Co., LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Yang

13911876975 yanghui1234359@sina.com

View on ClinicalTrials.gov More Peptic Ulcer Bleeding trials