NCT03980496

Effects of Different Omeprazole Dosing on Gastric pH in Non-variceal Upper Gastrointestinal Bleeding

Effects of Different Omeprazole Dosing on Gastric pH in Non- Variceal Upper Gastrointestinal Bleeding: A Randomized Prospective Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to identify the best method of omeprazole (OME) application with respect to intragastric pH, cytochrome P450 2C19 (CYP2C19) genotype and phenotype.

Detailed description

The patients with non-variceal upper gastrointestinal bleeding (NVUGIB) are prospectively enrolled. After the achievement of endoscopic hemostasis, the patients are randomized to 40-mg intravenous (i.v.) OME bolus injection every 12 h or 8-mg/h continuous i.v. infusion for 72 h after an 80-mg i.v. OME bolus administration. The intragastric pH is recorded for 72 h. The CYP2C19 variant alleles (\*2, \*3, \*17) are analyzed and the serum concentrations of OME and 5-hydroxyomeprazole (5-OH OME) are determined. The diagnosis of Helicobacter pylori infection was based on the results of the rapid urease test performed on stomach mucosa biopsies (antrum and angle) and on the results of the stool antigen test.

Conditions

• Non-variceal Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DRUG	Omeprazole

Timeline

• Start date: 2010-09-09
• Primary completion: 2013-06-08
• Completion: 2013-06-08
• First posted: 2019-06-10
• Last updated: 2019-06-10

Locations

1 site across 1 country: Poland