A Phase 4 interventional study of Omeprazole in Non-variceal Upper Gastrointestinal Bleeding, sponsored by Medical University of Bialystok. Completed at 1 site in Poland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by Medical University of Bialystok · Phase 4, Interventional, and Treatment
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.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 50 is below the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.
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After successful endoscopic hemostasis, the patients are given an 80-mg i.v. omeprazole bolus. The OI group is then treated with an 8-mg/h continuous i.v. infusion of OME for 72 h.
Drug: Omeprazole
After successful endoscopic hemostasis, the patients are given an 80-mg i.v. omeprazole bolus. The OB group receives a 40-mg i.v. bolus of OME every 12 h.
Drug: Omeprazole
Also known as: endoscopic treatment of non-variceal upper gastrointestinal bleeding
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Percentage of time at pH >4.0 and pH >6.0
intragastric pH profiles
Time frame: 72 hours
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: pH at specified time after the initial OME 80 mg i.v. bolus
intragastric pH profiles
Time frame: 72 hours
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection
intragastric pH profiles
Time frame: 72 hours
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)
intragastric pH profiles
Time frame: 72 hours
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Medical University of Bialystok