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

This study has been completed.
Sponsor:
Information provided by:
Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:
NCT00374101
First received: September 7, 2006
Last updated: April 4, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Peptic Ulcers
Upper Gastrointestinal Bleeding
Drug: omeprazole
Drug: pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Casa Sollievo della Sofferenza IRCCS:

Primary Outcome Measures:
  • Rebleeding rates and surgical needs

Estimated Enrollment: 450
Study Start Date: January 2005
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00374101

Locations
Italy
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
Investigators
Principal Investigator: Andriulli Angelo, MD Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00374101     History of Changes
Other Study ID Numbers: 18/2004
Study First Received: September 7, 2006
Last Updated: April 4, 2007
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 19, 2014