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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 8, 2013

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.

Interventions

  • Drug: Omeprazole

Arms, Groups and Cohorts

  • Active Comparator: omeprazole infusion (OI) group
    • 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.
  • Active Comparator: omeprazole bolus (OB) group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Bialystok
  • Collaborator
    • National Science Centre, Poland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrzej Dabrowski, Prof., Study Chair, Medical University of Bialystok

Citations Reporting on Results

Chwiesko A, Charkiewicz R, Niklinski J, Luczaj W, Skrzydlewska E, Milewski R, Baniukiewicz A, Wroblewski E, Rosolowski M, Dabrowski A. Effects of different omeprazole dosing on gastric pH in non-variceal upper gastrointestinal bleeding: A randomized prospective study. J Dig Dis. 2016 Sep;17(9):588-599. doi: 10.1111/1751-2980.12393.

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