Skip to main content
OpenTrials
Completed

NCT Number: NCT00731601

Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lotung Poh-Ai hospital

Yilan, 26514, Taiwan

About this study

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.

In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .

The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.

Exclusion criteria

  • If patients were pregnant
  • Did not obtain initial hemostasis with endoscopic injection of epinephrine
  • Did not give written informed consent
  • Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.

Treatment and study plan

Pantoprazole

Drug

pantoprazole 40 mg/q6h IV infusion for three days

Other names: pantoloc

Primary outcomes

  1. The primary end point was recurrent bleeding before discharge and within 14 days.

    Time frame: About one year

Secondary outcomes

  1. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.

    Time frame: about one year

Sponsors and collaborators

Lead sponsor

Lotung Poh-Ai Hospital

Other

Registry information

Official study title

Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial

Acronym: PPI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 11, 2008
Registry last updated
Apr 7, 2009

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.