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...
Date First Received: December 13, 2007
Last Updated: March 24, 2009
Verified by: University of Southern California, March 2008
Clinical Trial Phase: N/A | Start Date: February 2006
Overall Status: Completed
Estimated Enrollment: 66
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
Intervention(s) in this Clinical Trial
- Drug: Proton pump inhibitor (lansoprazole)
- 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Oral PPI
- Active Comparator: 2
- Intravenous PPI
Outcome Measures for this Clinical Trial
Primary Measures
- Intragastric pH > 6
- Time Frame: 24 hours
Safety Issue?: No
- Time Frame: 24 hours
Secondary Measures
- Mean intragastric pH
- Time Frame: 24 hrs
Safety Issue?: No
- Time Frame: 24 hrs
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Southern California
Overall Clinical Trial Officials and Contacts
Loren Laine, M.D. Principal Investigator University of Southern California
Related Publications
Citations Reporting Results
Laine L, Shah A, Bemanian S. Intragastric pH with oral vs intravenous bolus plus infusion proton-pump inhibitor therapy in patients with bleeding ulcers. Gastroenterology. 2008 Jun;134(7):1836-41. Epub 2008 Mar 10.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573924
Study ID Number: HS-06-00014
ClinicalTrials.gov Identifier: NCT00573924
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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