Skip to main content
OpenTrials
Completed

NCT Number: NCT05005910

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peptic Ulcer With Haemorrhage Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vonoprazan

Drug

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

PPIs IV infusion

Drug

Pantoprazole 80 mg IV loading then 8 mg/hr

Primary outcomes

  1. Rebleeding rate

    Time frame: 30 days

Secondary outcomes

  1. Rebleeding rate

    Time frame: 3 days

  2. Mortality rate

    Time frame: 30 days

  3. Number of blood transfusion unit

    Time frame: 30 days

  4. Rate of immobilisation or surgery

    Time frame: 30 days

  5. Length of stay

    Time frame: Until discharge, assessed up to 30 days

Sponsors and collaborators

Lead sponsor

Uayporn Kaosombatwattana

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.