BleedingNCT07772700
Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding
A study testing Vonoprazon and Esomeprazole in people with Bleeding, run by National Cheng-Kung University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Vonoprazon and Esomeprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients > 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bleeding
- Being tested
- Vonoprazon, Esomeprazole
- Keywords
- PCAB, PPI, peptic ulcer bleeding, Rockall score, rebleeding
- Medical subject headings
- Hemorrhage, Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazonDrug
After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days.
EsomeprazoleDrug
After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days. Receives: Drug: Vonoprazon |
| Standard group | Active comparator | After 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days. Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (2)
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Measured: 28 days
Mortality
All cause mortality within 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous pharmacological therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the intervention group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsueh-Chien Chiang, National Cheng-Kung University Hospital
- Investigators
- Hsueh-Chien Chiang, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772700
- Sponsor's protocol ID
- A-BR-115-053
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, the patients' data can be shared by readers' demand
Publications
Cheng HC, Wu CT, Chang WL, Cheng WC, Chen WY, Sheu BS. Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study. Gut. 2014 Dec;63(12):1864-72. doi: 10.1136/gutjnl-2013-306531. Epub 2014 Mar 21.
PubMed 24658598Yang EH, Wu CT, Kuo HY, Chen WY, Sheu BS, Cheng HC. The recurrent bleeding risk of a Forrest IIc lesion at the second-look endoscopy can be indicated by high Rockall scores >/= 6. Surg Endosc. 2020 Apr;34(4):1592-1601. doi: 10.1007/s00464-019-06919-3. Epub 2019 Jun 20.
PubMed 31222633Yang EH, Cheng HC, Wu CT, Chen WY, Lin MY, Sheu BS. Peptic ulcer bleeding patients with Rockall scores >/=6 are at risk of long-term ulcer rebleeding: A 3.5-year prospective longitudinal study. J Gastroenterol Hepatol. 2018 Jan;33(1):156-163. doi: 10.1111/jgh.13822.
PubMed 28497645Kyaw MH, Lau JYW. High Rate of Mortality More Than 30 Days After Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1858-1859. doi: 10.1016/j.cgh.2017.08.002. Epub 2017 Aug 10. No abstract available.
PubMed 28804035Laine L. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016 Sep 22;375(12):1198. doi: 10.1056/NEJMc1609017. No abstract available.
PubMed 27653581Jang Y, Park J, Kang D, Kim JH, Choi HS, Jeon HL, Lee H. Safety of Potassium-Competitive Acid Blockers Compared With Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease and Peptic Ulcer Disease: A Systematic Review and Meta-Analysis. J Gastroenterol Hepatol. 2026 Jan;41(1):28-40. doi: 10.1111/jgh.70178. Epub 2025 Dec 2.
PubMed 41330871
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07772700
- Acronym / sponsor ID
- A-BR-115-053
- Conditions
- Bleeding
- Keywords
- PCAB, PPI, peptic ulcer bleeding, Rockall score, rebleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous pharmacological therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the intervention group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: VonoprazonAfter 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days. |
| Standard group | Active comparator | Drug: EsomeprazoleAfter 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients > 18 years with upper gastrointestinal ulcer bleeding, a Rockall score of 6 or higher, and treatment with endoscopic hemostasis.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazonAfter 72 hours continuous intravenous PPI, patients in the intervention group will receive vonoprazon 20mg per day for 28 days. | Drug | Intervention Group |
| EsomeprazoleAfter 72 hours continuous intravenous PPI, patients in the intervention group will receive esomeprazole 40mg twice a day for 28 days. | Drug | Standard group |
Primary outcome
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.
2 secondary outcomes
Requirement for transcatheter arterial embolization or surgical hemostasis because of recurrent bleeding
Time frame: 28 days
Mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 24658598Cheng HC, Wu CT, Chang WL, Cheng WC, Chen WY, Sheu BS. Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study. Gut. 2014 Dec;63(12):1864-72. doi: 10.1136/gutjnl-2013-306531. Epub 2014 Mar 21.
- Background: PubMed 31222633Yang EH, Wu CT, Kuo HY, Chen WY, Sheu BS, Cheng HC. The recurrent bleeding risk of a Forrest IIc lesion at the second-look endoscopy can be indicated by high Rockall scores >/= 6. Surg Endosc. 2020 Apr;34(4):1592-1601. doi: 10.1007/s00464-019-06919-3. Epub 2019 Jun 20.
- Background: PubMed 28497645Yang EH, Cheng HC, Wu CT, Chen WY, Lin MY, Sheu BS. Peptic ulcer bleeding patients with Rockall scores >/=6 are at risk of long-term ulcer rebleeding: A 3.5-year prospective longitudinal study. J Gastroenterol Hepatol. 2018 Jan;33(1):156-163. doi: 10.1111/jgh.13822.
- Background: PubMed 28804035Kyaw MH, Lau JYW. High Rate of Mortality More Than 30 Days After Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1858-1859. doi: 10.1016/j.cgh.2017.08.002. Epub 2017 Aug 10. No abstract available.
- Background: PubMed 27653581Laine L. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016 Sep 22;375(12):1198. doi: 10.1056/NEJMc1609017. No abstract available.
- Background: PubMed 41330871Jang Y, Park J, Kang D, Kim JH, Choi HS, Jeon HL, Lee H. Safety of Potassium-Competitive Acid Blockers Compared With Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease and Peptic Ulcer Disease: A Systematic Review and Meta-Analysis. J Gastroenterol Hepatol. 2026 Jan;41(1):28-40. doi: 10.1111/jgh.70178. Epub 2025 Dec 2.
- Individual participant dataSharing planned: Yes. After publication, the patients' data can be shared by readers' demand
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsueh-Chien Chiang, MD principal investigator
National Cheng-Kung University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazon and Esomeprazole in people with Bleeding, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng-Hsuan Lu, MD (8862353535, cyes40327@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent bleeding (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07772700, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.