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

Primary Purpose

Peptic Ulcers, Upper Gastrointestinal Bleeding

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
omeprazole
pantoprazole
Sponsored by
Casa Sollievo della Sofferenza IRCCS
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcers focused on measuring PPIs,, endoscopic therapy,, peptic ulcers,, upper gastrointestinal bleeding,, non-variceal upper gastrointestinal bleeding

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Internal Medicine
  • Division of Gastroenterology
  • DIvision of Gastroenterology
  • Division of Gastroenterology
  • DIvision of Internal Medicine
  • Division of Gastroenterology
  • Division of Gastroenterology
  • Division of Gastroenterology
  • Division of Gastroenterology
  • Division of Gastroenterology

Outcomes

Primary Outcome Measures

Rebleeding rates and surgical needs

Secondary Outcome Measures

Full Information

First Posted
September 7, 2006
Last Updated
April 4, 2007
Sponsor
Casa Sollievo della Sofferenza IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT00374101
Brief Title
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

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Casa Sollievo della Sofferenza IRCCS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcers, Upper Gastrointestinal Bleeding
Keywords
PPIs,, endoscopic therapy,, peptic ulcers,, upper gastrointestinal bleeding,, non-variceal upper gastrointestinal bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
omeprazole
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Primary Outcome Measure Information:
Title
Rebleeding rates and surgical needs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andriulli Angelo, MD
Organizational Affiliation
Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Internal Medicine
City
Polla
State/Province
Salerno
Country
Italy
Facility Name
Division of Gastroenterology
City
Caserta
Country
Italy
Facility Name
DIvision of Gastroenterology
City
Como
Country
Italy
Facility Name
Division of Gastroenterology
City
Cosenza
Country
Italy
Facility Name
DIvision of Internal Medicine
City
Ivrea
Country
Italy
Facility Name
Division of Gastroenterology
City
Piacenza
Country
Italy
Facility Name
Division of Gastroenterology
City
San Giovanni Rotondo
Country
Italy
Facility Name
Division of Gastroenterology
City
Torino
Country
Italy
Facility Name
Division of Gastroenterology
City
Treviso
Country
Italy
Facility Name
Division of Gastroenterology
City
Vasto
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15654802
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.
Results Reference
background
PubMed Identifier
19086953
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.
Results Reference
derived

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

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