Peptic Ulcer Hemorrhage
Conditions
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.
Interventions
DRUGProton pump inhibitor (lansoprazole)
1. 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs 2. 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intragastric pH > 6 | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Mean intragastric pH | 24 hrs |
Countries
United States
Outcome results
None listed