Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding (PPI)

April 6, 2009 updated by: Lotung Poh-Ai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Yilan, Taiwan, 26514
        • Lotung Poh-Ai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
pantoprazole 40mg/q6h IV infusion for three days
Drug: pantoprazole
pantoprazole 40 mg/q6h IV infusion for three days
Other Names:
  • pantoloc
Drug: pantoprazole
pantoprazole 8 mg/h IV infusion for three days
Other Names:
  • pantoloc
Active Comparator: 2
pantoprazole 8mg/h for three days
Drug: pantoprazole
pantoprazole 40 mg/q6h IV infusion for three days
Other Names:
  • pantoloc
Drug: pantoprazole
pantoprazole 8 mg/h IV infusion for three days
Other Names:
  • pantoloc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point was recurrent bleeding before discharge and within 14 days.
Time Frame: About one year
About one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
about one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lotung Poh-Ai Hospital

Investigators

  • Principal Investigator: Hwai-jeng Lin, M.D., Lotung Poh-Ai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 6, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LotungPAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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