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

June 7, 2019 updated by: Medical University of Bialystok

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-276
        • Department of Gastroenterology and Internal Medicine, Medical University of Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Omeprazole
Other Names:
  • endoscopic treatment of non-variceal upper gastrointestinal bleeding
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.
Drug: Omeprazole
Other Names:
  • endoscopic treatment of non-variceal upper gastrointestinal bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 72 hours
intragastric pH profiles
72 hours
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection
Time Frame: 72 hours
intragastric pH profiles
72 hours
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Collaborators

National Science Centre, Poland

Investigators

  • Study Chair: Andrzej Dabrowski, Prof., Medical University of Bialystok

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2010

Primary Completion (ACTUAL)

June 8, 2013

Study Completion (ACTUAL)

June 8, 2013

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (ACTUAL)

June 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N N402 462539
  • 4625/B/P01/2010/39 (OTHER: Polish National Science Centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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