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

Phase 4

Completed

• Conditions: Non-variceal Upper Gastrointestinal Bleeding
• Interventions: Drug: Omeprazole

• Registration Number: NCT03980496
• Lead Sponsor: Medical University of Bialystok

Brief 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.

Study Timeline

• Study Start: 2010-09-09
• Primary Completion: 2013-06-08
• Study Completion: 2013-06-08
• Status Verified: 2019-06
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• written informed consent must be obtained before any treatment or assessment is performed
• patients admitted with upper gastrointestinal bleeding (UGIB) symptoms to the Emergency Department of the University Hospital of Bialystok (Bialystok, Poland)

Exclusion Criteria

• pregnancy
• age >90 years
• lack of written consent
• recent treatment with certain medications, including PPIs, H2-receptor antagonists (H2RA), antacids, steroids, oral contraceptives, clopidogrel, prasugrel and clarithromycin
• the presence of variceal UGIB
• history of surgery of upper gastro-intestinal tract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omeprazole infusion (OI) group	Omeprazole	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.
omeprazole bolus (OB) group	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.

Primary Outcome Measures

Name	Time	Method
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Percentage of time at pH >4.0 and pH >6.0	72 hours	intragastric pH profiles
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	72 hours	intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection	72 hours	intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)	72 hours	intragastric pH profiles

Trial Locations

Locations (1)

Department of Gastroenterology and Internal Medicine, Medical University of Bialystok; 🇵🇱 Białystok, Podlaskie, Poland