An interventional study of Vonoprazon and Esomeprazole in Bleeding, sponsored by National Cheng-Kung University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Prevention
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.
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.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 108 is close to the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 esomeprazole 40mg twice a day for 28 days.
Drug: Esomeprazole
After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.
After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.
Recurrent bleeding
If melena or hematochezia occurs during follow-up, endoscopy will be performed to determine whether recurrent bleeding originates from the original bleeding lesion.
Time frame: 28 days
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Time frame: 28 days
Mortality
All cause mortality within 28 days
Time frame: 28 days
No study locations are listed for this record.
Plan to share: Yes — After publication, the patients' data can be shared by readers' demand
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 191 non-industry interventional studies with no phase under Hemorrhage, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 15 months is below that.
Counting every sponsor, half of 226 studies reached it within 19 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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