Clinical trial NCT00374101: High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Official title: Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peptic Ulcers
Upper Gastrointestinal Bleeding
Keywords: PPIs,
endoscopic therapy,
peptic ulcers,
upper gastrointestinal bleeding,
non-variceal upper gastrointestinal bleeding
Lead sponsor: Casa Sollievo della Sofferenza IRCCS
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Rebleeding rates and surgical needs
Secondary outcomes:
Other outcomes:
Locations:
city: Polla
country: Italy
facility: Division of Internal Medicine
state: Salerno
city: Caserta
country: Italy
facility: Division of Gastroenterology
city: Como
country: Italy
facility: DIvision of Gastroenterology
city: Cosenza
country: Italy
facility: Division of Gastroenterology
city: Ivrea
country: Italy
facility: DIvision of Internal Medicine
city: Piacenza
country: Italy
facility: Division of Gastroenterology
city: San Giovanni Rotondo
country: Italy
facility: Division of Gastroenterology
city: Torino
country: Italy
facility: Division of Gastroenterology
city: Treviso
country: Italy
facility: Division of Gastroenterology
city: Vasto
country: Italy
facility: Division of Gastroenterology
Study officials:
affiliation: Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
name: Andriulli Angelo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.