High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

Last updated: April 4, 2007
Sponsor: Casa Sollievo della Sofferenza IRCCS
Overall Status: Completed

Phase

3

Condition

Ulcers

Gastrointestinal Diseases And Disorders

Gastric Ulcers

Treatment

N/A

Clinical Study ID

NCT00374101
18/2004
  • Ages 18-90
  • All Genders

Study Summary

High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consecutive patients admitted for upper gastrointestinal bleeding secondary to pepticulcers that have been successfully treated with endoscopic therapy

Exclusion

Exclusion Criteria:

  • Variceal esophageal bleeding

  • Concurrent PPI use

  • Moribund patients

Study Design

Total Participants: 450
Study Start date:
January 01, 2005
Estimated Completion Date:
March 31, 2007

Study Description

The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.

Connect with a study center

  • Division of Internal Medicine

    Polla, Salerno
    Italy

    Site Not Available

  • Division of Gastroenterology

    Caserta,
    Italy

    Site Not Available

  • DIvision of Gastroenterology

    Como,
    Italy

    Site Not Available

  • Division of Gastroenterology

    Cosenza,
    Italy

    Site Not Available

  • DIvision of Internal Medicine

    Ivrea,
    Italy

    Site Not Available

  • Division of Gastroenterology

    Piacenza,
    Italy

    Site Not Available

  • Division of Gastroenterology

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • Division of Gastroenterology

    Torino,
    Italy

    Site Not Available

  • Division of Gastroenterology

    Treviso,
    Italy

    Site Not Available

  • Division of Gastroenterology

    Vasto,
    Italy

    Site Not Available

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