High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Information source: Casa Sollievo della Sofferenza IRCCS
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peptic Ulcers; Upper Gastrointestinal Bleeding
Intervention: omeprazole (Drug); pantoprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Casa Sollievo della Sofferenza IRCCS Official(s) and/or principal investigator(s):
Andriulli Angelo, MD, Principal Investigator, Affiliation: Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
Summary
High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in
bleeding peptic ulcers successfully treated by endoscopic therapy
Clinical Details
Official title: Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: Rebleeding rates and surgical needs
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Division of Gastroenterology, Treviso, Italy
Division of Gastroenterology, Caserta, Italy
Division of Gastroenterology, Cosenza, Italy
Division of Gastroenterology, Torino, Italy
DIvision of Internal Medicine, Ivrea, Italy
Division of Gastroenterology, Piacenza, Italy
DIvision of Gastroenterology, Como, Italy
Division of Gastroenterology, Vasto, Italy
Division of Gastroenterology, San Giovanni Rotondo, Italy
Division of Internal Medicine, Polla, Salerno, Italy
Additional Information
Related publications: Andriulli A, Annese V, Caruso N, Pilotto A, Accadia L, Niro AG, Quitadamo M, Merla A, Fiorella S, Leandro G. Proton-pump inhibitors and outcome of endoscopic hemostasis in bleeding peptic ulcers: a series of meta-analyses. Am J Gastroenterol. 2005 Jan;100(1):207-19.
Starting date: January 2005
Ending date: March 2007
Last updated: April 4, 2007
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