NCT06783257

Phase II Clinical Study of Vonorasan Fumarate Injection in 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Vonorasan fumarate injection1	40 mg (20 mg bid, 6 hours apart, Day1) + 20 mg (Day2\&3, q24h), ivd, 30 min, administered for 3 days
DRUG	Vonorasan fumarate injection2	40mg（Day1）+20mg（Day 2\&3），ivd，30min，q24h，administered for 3 days
DRUG	Esomeprazole sodium for injection	80mg，iv，30±3min； Followed by 8 mg/h, ivd, 71.5 h

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-01-20
• Last updated: 2025-01-20