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NOT YET RECRUITING
NCT06783257
PHASE2

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

Sponsor: Shandong New Time Pharmaceutical Co., LTD

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-02

Completion Date

2027-02

Last Updated

2025-01-20

Healthy Volunteers

No

Interventions

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