Could a simple pill replace IV drips for bleeding ulcers?
NCT ID NCT05582174
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares an oral medication called Vonoprazan to the standard high-dose IV proton pump inhibitor (PPI) for preventing rebleeding in people with bleeding peptic ulcers after endoscopic treatment. About 594 adults will be randomly assigned to receive either oral Vonoprazan or IV esomeprazole for 72 hours, followed by oral medication for a month. The goal is to see if the oral option works just as well as the IV treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vonoprazan (oral) and esomeprazole (IV and oral)
- What this could lead to
- If successful, this could offer a simpler, oral-only treatment option to prevent rebleeding after endoscopic treatment for bleeding ulcers, potentially reducing hospital stays.
- What could go wrong
- This is a phase 4 trial, so the drugs are already approved, but it is still testing a new use. The main risk is that Vonoprazan may not be as effective as the standard IV PPI, leading to more rebleeding episodes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 594 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanfang Hospital Southern Medical University
RECRUITINGGuangzhou, Guangdong, China
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Prince of Wales Hospital
NOT_YET_RECRUITINGHong Kong, Hong Kong SAR, China
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Shenzhen Pingshan District People's Hospital
NOT_YET_RECRUITINGShenzhen, Guangdong, China
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The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen
NOT_YET_RECRUITINGShenzhen, Guangdong, China
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The Second Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Yangjiang People's Hospital of Guangdong Medical University
NOT_YET_RECRUITINGYangjiang, Guangdong, China
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Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University)
NOT_YET_RECRUITINGZhuhai, Guangdong, China
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