🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05582174
Recruiting Phase 4

PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

NCT05582174 · tracked via the Priya Life Science China tracker
Sponsor
Chinese University of Hong Kong
Phase
Phase 4
Started
2023-05-18
Last updated
2026-03-18

Condition(s) studied

Upper GI BleedingProton Pump Inhibitors

Investigational drug(s) / intervention(s)

Vonoprazan →esomeprazole →

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * \- Patients aged ≥18 years who had undergone oesophagogastroduodenoscopy (OGD) for sign and symptoms of aneamia or upper GI bleeding including haematochezia, melaena or haematemesis, and found to a non-variceal upper GI cause of bleeding (peptic ulcers, dieulafoy's lesions, Mallory Weiss tear with active bleeding or major stigmata of haemorrhage * Major stigmata of recent haemorrhage includes peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) ,with a nonbleeding visible vessel (Forrest classification IIa) or an adherent clot (Forrest classification IIb). For peptic ulcers with an adherent clot (Forrest classification IIb), the clot would be lifted (by irrigation using syringe boluses or water pump device, or manipulation with a snare or alligator etc.) and ulcer base examined to look for underlying vessels. Once the clot is removed, any identified underlying active bleeding or nonbleeding visible vessel should receive endoscopic haemostasis * Patients who had undergone endoscopic hemostatic treatment (a combination of hemoclipping therapy or contact thermocoagulation using multipolar/bipolar electrocautery probes or haemostatic forceps, with or without preinjection of diluted epinephrine. Endoscopic haemostasis is defined as no evidence of bleeding after irrigation and 3 minutes of observation Exclusion Criteria: * No consent * Patients under the age of 18 * Patients who were pregnant or in lactation * Hypersensitivity to PPI or Vonoprazan or any component of the formulation * Patients who were found to have tumour bleeding, oesophageal varices as the cause of the NVGIB * NVGIB due to post therapeutic endoscopic treatment such as gastric polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection etc.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Nanfang Hospital Southern Medical University Guangzhou Guangdong Recruiting
The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong Not Yet Recruiting
Shenzhen Pingshan District People's Hospital Shenzhen Guangdong Not Yet Recruiting
The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen Shenzhen Guangdong Not Yet Recruiting
Yangjiang People's Hospital of Guangdong Medical University Yangjiang Guangdong Not Yet Recruiting
Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University) Zhuhai Guangdong Not Yet Recruiting
Prince of Wales Hospital Hong Kong Hong Kong SAR Not Yet Recruiting

On this site

📄 Nexium (esomeprazole) drug profile →

More Chinese University of Hong Kong trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05582174 on ClinicalTrials.gov ↗ ← All trials in China