High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding - Full Text View

Sponsor:	Casa Sollievo della Sofferenza IRCCS
Information provided by:	Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:	NCT00374101

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding Peptic Ulcer

Drug Information available for: Omeprazole Omeprazole magnesium Pantoprazole Pantoprazole Sodium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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

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

Locations

Italy
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
Italy, Salerno
Division of Internal Medicine
Polla, Salerno, 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:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Andriulli A, Loperfido S, Focareta R, Leo P, Fornari F, Garripoli A, Tonti P, Peyre S, Spadaccini A, Marmo R, Merla A, Caroli A, Forte GB, Belmonte A, Aragona G, Imperiali G, Forte F, Monica F, Caruso N, Perri F. High- versus low-dose proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding: a multicentre, randomized study. Am J Gastroenterol. 2008 Dec;103(12):3011-8.

Study ID Numbers:	18/2004
Study First Received:	September 7, 2006
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00374101 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ulcer
Pantoprazole
Gastrointestinal Agents
Gastrointestinal Hemorrhage
Omeprazole
Enzyme Inhibitors
Hemorrhage
Intestinal Diseases

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Stomach Diseases
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Peptic Ulcer
Duodenal Diseases

ClinicalTrials.gov processed this record on February 08, 2010