RecruitingPhase 4NCT05582174

PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

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


Sponsor

Chinese University of Hong Kong

Enrollment

594 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vonoprazan and a drug called esomeprazole for people with proton pump inhibitors and upper gi bleeding. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVonoprazan

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

DRUGesomeprazole

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

View Full Details on ClinicalTrials.gov

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NCT05582174


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