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Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Primary Purpose

Peptic Ulcer With Haemorrhage

Status

Recruiting

Phase

Early Phase 1

Locations

Thailand

Study Type

Interventional

Intervention

Vonoprazan

PPIs IV infusion

About this trial

This is an interventional treatment trial for Peptic Ulcer With Haemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of internal medicine siriraj hospital, Mahidol universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vonoprazan

PPIs

Arm Description

Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days

PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days

Outcomes

Primary Outcome Measures

Rebleeding rate

Secondary Outcome Measures

Rebleeding rate

Mortality rate

Number of blood transfusion unit

Rate of immobilisation or surgery

Length of stay

Full Information

NCT ID

NCT05005910

First Posted

December 12, 2020

Last Updated

September 26, 2022

Sponsor

Uayporn Kaosombatwattana

1. Study Identification

Unique Protocol Identification Number

NCT05005910

Brief Title

Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Official Title

Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Uayporn Kaosombatwattana

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peptic Ulcer With Haemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vonoprazan

Arm Type

Experimental

Arm Description

Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days

Arm Title

PPIs

Arm Type

Active Comparator

Arm Description

PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days

Intervention Type

Drug

Intervention Name(s)

Vonoprazan

Intervention Description

Vonoprazan 20 mg oral every 12 hours (total 72 hours)

Intervention Type

Drug

Intervention Name(s)

PPIs IV infusion

Intervention Description

Pantoprazole 80 mg IV loading then 8 mg/hr

Primary Outcome Measure Information:

Title

Rebleeding rate

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Rebleeding rate

Time Frame

3 days

Title

Mortality rate

Time Frame

30 days

Title

Number of blood transfusion unit

Time Frame

30 days

Title

Rate of immobilisation or surgery

Time Frame

30 days

Title

Length of stay

Time Frame

Until discharge, assessed up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Faculty of internal medicine siriraj hospital, Mahidol university

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact: