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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374101
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : April 5, 2007
Information provided by:
Casa Sollievo della Sofferenza IRCCS

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

Condition or disease Intervention/treatment Phase
Peptic Ulcers Upper Gastrointestinal Bleeding Drug: omeprazole Drug: pantoprazole Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
Study Start Date : January 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Rebleeding rates and surgical needs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Variceal esophageal bleeding
  • Concurrent PPI use
  • Moribund patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374101

Division of Internal Medicine
Polla, Salerno, Italy
Division of Gastroenterology
Caserta, Italy
DIvision of Gastroenterology
Como, Italy
Division of Gastroenterology
Cosenza, Italy
DIvision of Internal Medicine
Ivrea, Italy
Division of Gastroenterology
Piacenza, Italy
Division of Gastroenterology
San Giovanni Rotondo, Italy
Division of Gastroenterology
Torino, Italy
Division of Gastroenterology
Treviso, Italy
Division of Gastroenterology
Vasto, Italy
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Principal Investigator: Andriulli Angelo, MD Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00374101     History of Changes
Other Study ID Numbers: 18/2004
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: April 5, 2007
Last Verified: April 2007

Keywords provided by Casa Sollievo della Sofferenza IRCCS:
endoscopic therapy,
peptic ulcers,
upper gastrointestinal bleeding,
non-variceal upper gastrointestinal bleeding

Additional relevant MeSH terms:
Peptic Ulcer
Gastrointestinal Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action