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

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ClinicalTrials.gov Identifier: NCT03980496
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
National Science Centre, Poland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-variceal Upper Gastrointestinal Bleeding Drug: Omeprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Different Omeprazole Dosing on Gastric pH in Non- Variceal Upper Gastrointestinal Bleeding: A Randomized Prospective Study
Actual Study Start Date : September 9, 2010
Actual Primary Completion Date : June 8, 2013
Actual Study Completion Date : June 8, 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: endoscopic treatment of non-variceal upper gastrointestinal bleeding




Primary Outcome Measures :
  1. 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

  2. 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

  3. Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection [ Time Frame: 72 hours ]
    intragastric pH profiles

  4. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980496


Locations
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Poland
Department of Gastroenterology and Internal Medicine, Medical University of Bialystok
Białystok, Podlaskie, Poland, 15-276
Sponsors and Collaborators
Medical University of Bialystok
National Science Centre, Poland
Investigators
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Study Chair: Andrzej Dabrowski, Prof. Medical University of Bialystok

Additional Information:
Publications of Results:
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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03980496     History of Changes
Other Study ID Numbers: N N402 462539
4625/B/P01/2010/39 ( Other Identifier: Polish National Science Centre )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

Keywords provided by Medical University of Bialystok:
CYP2C19
Helicobacter pylori
non-variceal upper gastrointestinal bleeding
intragastric pH
proton pump inhibitor

Additional relevant MeSH terms:
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Omeprazole
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action