Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding

August 18, 2026 updated by: Hsueh-Chien Chiang, National Cheng-Kung University Hospital

Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding: A Randomized Controlled Trial

This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.

A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.

Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Upper gastrointestinal bleeding is a common clinical condition associated with a substantial risk of mortality, with ulcer bleeding accounting for the majority of cases. Current standard treatment consists of pharmacological therapy combined with endoscopic hemostasis. Pharmacological therapy suppresses gastric acid secretion, reduces clot dissolution, and creates an environment conducive to mucosal healing.

Various scoring systems are used clinically to assess disease severity and prognosis in patients with ulcer bleeding. The Rockall score is one of the most commonly used systems. Patients with a Rockall score of 6 or higher have a higher risk of rebleeding and mortality. Therefore, high-risk patients are generally treated with twice-daily oral proton pump inhibitors (PPIs). However, twice-daily dosing may reduce medication adherence.

Potassium-competitive acid blockers (P-CABs) have emerged in recent years and offer several potential advantages, including rapid onset of action, potent acid suppression, stability in an acidic environment, and a long half-life. They may represent a new treatment option for peptic-ulcer disease. This study will therefore compare the efficacy of PPI and P-CAB therapy in preventing recurrent bleeding among patients with upper gastrointestinal ulcer bleeding and a Rockall score of 6 or higher.

This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher.

A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients.

Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized patients > 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis.

Exclusion Criteria:

  • history of hypersensitivity to PPIs or P-CABs.
  • non-ulcer-related bleeding, such as variceal bleeding, angiodysplasia, diverticular bleeding, diffuse mucosal bleeding, or tumor bleeding.
  • severe hepatic or renal impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.
Drug: Vonoprazon
After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.
Active Comparator: Standard group
After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.
Drug: Esomeprazole
After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent bleeding
Time Frame: 28 days
If melena or hematochezia occurs during follow-up, endoscopy will be performed to determine whether recurrent bleeding originates from the original bleeding lesion.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Time Frame: 28 days
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
28 days
Mortality
Time Frame: 28 days
All cause mortality within 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Hsueh-Chien Chiang, MD, National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 14, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-115-053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication, the patients' data can be shared by readers' demand

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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