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

Overview[ - collapse ][ - ]

Purpose High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy
ConditionPeptic Ulcers
Upper Gastrointestinal Bleeding
InterventionDrug: omeprazole
Drug: pantoprazole
PhasePhase 3
SponsorCasa Sollievo della Sofferenza IRCCS
Responsible PartyCasa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov IdentifierNCT00374101
First ReceivedSeptember 7, 2006
Last UpdatedApril 4, 2007
Last verifiedApril 2007

Tracking Information[ + expand ][ + ]

First Received DateSeptember 7, 2006
Last Updated DateApril 4, 2007
Start DateJanuary 2005
Estimated Primary Completion DateMarch 2007
Current Primary Outcome MeasuresRebleeding rates and surgical needs
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleHigh Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Official TitleProton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
Brief Summary
High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in
bleeding peptic ulcers successfully treated by endoscopic therapy
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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition
  • Peptic Ulcers
  • Upper Gastrointestinal Bleeding
InterventionDrug: omeprazole
Drug: pantoprazole
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment450
Estimated Completion DateMarch 2007
Estimated Primary Completion DateNot Provided
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesItaly

Administrative Information[ + expand ][ + ]

NCT Number NCT00374101
Other Study ID Numbers18/2004
Has Data Monitoring CommitteeNo
Information Provided ByCasa Sollievo della Sofferenza IRCCS
Study SponsorCasa Sollievo della Sofferenza IRCCS
CollaboratorsNot Provided
Investigators Principal Investigator: Andriulli Angelo, MD Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
Verification DateApril 2007

Locations[ + expand ][ + ]

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