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RECRUITING
NCT05582174
PHASE4

PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

Vonoprazan (VPZ), an oral potassium-competitive acid blocker (P-CAB) has emerged as an alternative potent acid-suppressant.It has a faster onset of action in 1 day (3-5 days in PPI), and is more stable in acidic condition than PPI. While many studies compared Vonoprazan against PPI in the treatment of reflux oesophagitis, H. Pylori eradication, and gastric ulcers; thus far, there is a paucity of data on use of Vonoprazan on bleeding peptic ulcers. We perform a multicenter randomized controlled trial (RCT) to compare the efficacy of oral Vonoprazan against standard high dose PPI therapy in bleeding peptic ulcers that had received successful endoscopic haemostasis We hypothesize that in patients with bleeding peptic ulcers, the use of acid pump inhibitors Vonoprazan would not be inferior to standard treatment of a bolus plus high dose PPI intravenous infusion at preventing recurrent bleeding after endoscopic haemostasis.

Official title: A Comparison Between a High Dose PPI Intravenous Infusion and Oral Acid Pump Inhibitors After Endoscopic Haemostasis to Bleeding Peptic Ulcers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

594

Start Date

2023-05-18

Completion Date

2028-07-03

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Vonoprazan

Vonoprazan 40 mg bid orally for 72 hours, and from day 4-30 VPZ 20 mg daily

DRUG

esomeprazole

A high dose PPI infusion (esomeprazole 80mg iv bolus followed by 8mg per hour for 72 hours), and frorm day 4-30 oral esomeprazole daily

Locations (8)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Shenzhen Pingshan District People's Hospital

Shenzhen, Guangdong, China

The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Yangjiang People's Hospital of Guangdong Medical University

Yangjiang, Guangdong, China

Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University)

Zhuhai, Guangdong, China

Prince of Wales Hospital

Hong Kong, Hong Kong SAR, China