High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
1 other identifier
interventional
450
1 country
10
Brief Summary
High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedApril 5, 2007
April 1, 2007
September 7, 2006
April 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rebleeding rates and surgical needs
Interventions
Eligibility Criteria
You may qualify if:
- Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy
You may not qualify if:
- Variceal esophageal bleeding
- Concurrent PPI use
- Moribund patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Division of Internal Medicine
Polla, Salerno, 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 Gastroenterology
San Giovanni Rotondo, Italy
Division of Gastroenterology
Torino, Italy
Division of Gastroenterology
Treviso, Italy
Division of Gastroenterology
Vasto, Italy
Related Publications (2)
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.
PMID: 15654802BACKGROUNDAndriulli 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.
PMID: 19086953DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andriulli Angelo, MD
Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
January 1, 2005
Study Completion
March 1, 2007
Last Updated
April 5, 2007
Record last verified: 2007-04