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Vonoprazan vs Pantoprazole for Post-EVL Ulcer Prevention
NCT05227833Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2022
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- Alexandria University
- Modality
- Small Molecules
- Drugs
- vonoprazan
- Conditions
- Esophageal ulcerGastrointestinal Bleeding (GIB)
01
Overview
Phase 3, randomised, open-label trial of vonoprazan in Esophageal ulcer and Gastrointestinal Bleeding (GIB) (3 arms), sponsored by Alexandria University. Primary endpoints: Post ligation ulcer presence, number, and size at 2 weeks and Post endoscopic variceal ligation bleeding at 2 weeks. Started Feb 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Vonoprazan
Vonoprazan 20 mg daily for 14 days.
Pantoprazole
Pantoprazole 40 mg daily for 14 days.
Placebo
No acid suppressive medications (No treatment).
03
Who it enrols
Patients with liver cirrhosis and portal hypertension eligible for endoscopic band ligation, excluding those with pre-existing ulcers, HCC, PVT, or renal impairment.
04
Endpoints
Primary
Post ligation ulcer presence, number, and size
Post endoscopic variceal ligation bleeding
Secondary
Number of participants with Vonoprazan-related adverse events
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