Clinical trial
Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis
Name
011/2563
Description
Upper gastrointestinal hemorrhage (UGIH) is common urgency condition.The estimate mortality rate about 7 percent from peptic ulcers disease(PUD). A proton pump inhibitors (PPIs) intravenous infusion are standard treatment for high risk ulcer bleeding. Vonoprazan,subclass of potassium-competitive acid blockers (P-CABs), have beneficial effects including rapid, long-lasting and strong acid suppression.The investigators design a randomized-controlled trial comparison between 72 hours of intravenous PPIs infusion and oral vonoprazan in high risk ulcer UGIH after achieve endoscopic hemostasis. Outcome measurement are re-bleeding rate in 30 days as primary and re-bleeding rate in 3 days, 30 days mortality, rate of angioembolisation, unit of blood transfusion, hospital cost and length of stay as secondary outcome.
Trial arms
Trial start
2021-09-01
Estimated PCD
2022-12-01
Trial end
2022-12-01
Status
Completed
Phase
Early phase I
Treatment
Vonoprazan
Vonoprazan 20 mg oral every 12 hours (total 72 hours)
Arms:
Vonoprazan
PPIs IV infusion
Pantoprazole 80 mg IV loading then 8 mg/hr
Arms:
PPIs
Size
194
Primary endpoint
Rebleeding rate
30 days
Eligibility criteria
Inclusion Criteria:
* High risk peptic ulcers bleeding (Forrest class Ia,Ib,IIa,IIb)
Exclusion Criteria:
* Patients were not achieve endoscopic hemostasis
* End stage cancer disease
* Severe critical illness and ICU setting
* Uncorrectable coagulopathy
* Pregnancy or breast feeding
* Allergy to PPIs or Vonoprazan
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 194, 'type': 'ACTUAL'}}
Updated at
2023-10-27
1 organization
2 products
1 indication
Organization
Uayporn KaosombatwattanaProduct
VonoprazanIndication
Peptic UlcerProduct
PPIs IV infusion