Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
Information source: University of Southern California
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peptic Ulcer Hemorrhage
Intervention: Proton pump inhibitor (lansoprazole) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Southern California Official(s) and/or principal investigator(s):
Loren Laine, M.D., Principal Investigator, Affiliation: University of Southern California
Summary
Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an
acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for
24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach
will be used to determine intragastric pH (a measure of the acid production in the stomach)
at baseline and during the 24 hours of therapy. The purpose of the study is to determine if
the continuous intravenous administration of the drug provides better reduction of acid in
the stomach than the oral administration.
Clinical Details
Official title: Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Intragastric pH > 6
Secondary outcome: Mean intragastric pH
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients presenting to hospital with overt upper GI bleeding and found to have an
ulcer as the cause on endoscopy
Exclusion Criteria:
- Previous gastric surgery
- Active bleeding at end of endoscopy (despite hemostatic therapy)
- Recent PPI or H2RA use
Locations and Contacts
L.A. County + U.S.C. Medical Center, Los Angeles, California 90033, United States
Additional Information
Starting date: February 2006
Ending date: December 2007
Last updated: March 18, 2008
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