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

NCT ID: NCT00374101

Last Updated: 2007-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Peptic Ulcers Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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omeprazole

Intervention Type DRUG

pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role lead

Principal Investigators

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Andriulli Angelo, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY

Locations

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Division of Internal Medicine

Polla, Salerno, Italy

Site Status

Division of Gastroenterology

Caserta, , Italy

Site Status

DIvision of Gastroenterology

Como, , Italy

Site Status

Division of Gastroenterology

Cosenza, , Italy

Site Status

DIvision of Internal Medicine

Ivrea, , Italy

Site Status

Division of Gastroenterology

Piacenza, , Italy

Site Status

Division of Gastroenterology

San Giovanni Rotondo, , Italy

Site Status

Division of Gastroenterology

Torino, , Italy

Site Status

Division of Gastroenterology

Treviso, , Italy

Site Status

Division of Gastroenterology

Vasto, , Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1111/j.1572-0241.2005.40636.x.

Reference Type BACKGROUND
PMID: 15654802 (View on PubMed)

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. doi: 10.1111/j.1572-0241.2008.02149.x.

Reference Type DERIVED
PMID: 19086953 (View on PubMed)

Other Identifiers

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18/2004

Identifier Type: -

Identifier Source: org_study_id