Back to resultsTrial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
Primary Purpose
Peptic Ulcer Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton pump inhibitor (lansoprazole)
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Hemorrhage
Eligibility 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
Sites / Locations
- L.A. County + U.S.C. Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Oral PPI
Intravenous PPI
Outcomes
Primary Outcome Measures
Intragastric pH > 6
Secondary Outcome Measures
Mean intragastric pH
Full Information
NCT ID
NCT00573924
First Posted
December 13, 2007
Last Updated
February 4, 2011
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT00573924
Brief Title
Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Oral PPI
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravenous PPI
Intervention Type
Drug
Intervention Name(s)
Proton pump inhibitor (lansoprazole)
Intervention Description
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
Primary Outcome Measure Information:
Title
Intragastric pH > 6
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Mean intragastric pH
Time Frame
24 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren Laine, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
L.A. County + U.S.C. Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18423628
Citation
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. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.
Results Reference
result
Learn more about this trial
Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
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