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

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374101
• Other study ID #: 18/2004
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2006
• Last updated: April 4, 2007
• Start date: January 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2007
• Source: Casa Sollievo della Sofferenza IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcers
• Ulcer
• Upper Gastrointestinal Bleeding

Intervention

Drug:
• omeprazole

• pantoprazole

Locations

Country	Name	City	State
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 Internal Medicine	Polla	Salerno
Italy	Division of Gastroenterology	San Giovanni Rotondo
Italy	Division of Gastroenterology	Torino
Italy	Division of Gastroenterology	Treviso
Italy	Division of Gastroenterology	Vasto

Sponsors (1)

Lead Sponsor	Collaborator
Casa Sollievo della Sofferenza IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding rates and surgical needs