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PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

NCT05582174 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2026-03-18

No results posted yet for this 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.

Conditions

  • Upper GI Bleeding
  • Proton Pump Inhibitors

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Side Liu, PhD · Southern Medical University - Southern Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2028-01-02
Completion
2028-07-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582174 on ClinicalTrials.gov