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

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

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Key information

Conditions

Peptic Ulcers Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Stomach Diseases Upper Gastrointestinal Bleeding

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Internal Medicine, Polla, Salerno, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

Pantoprazole

Drug

Primary outcomes

Rebleeding rates and surgical needs

Sponsors and collaborators

Lead sponsor

Casa Sollievo della Sofferenza IRCCS

Other

Registry information

Official study title

Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses

Important dates

Study start: 2005
Study completion: 2007
First posted: Sep 8, 2006
Registry last updated: Apr 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed