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

Primary Purpose

Non-variceal Upper Gastrointestinal Bleeding

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Omeprazole
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-variceal Upper Gastrointestinal Bleeding focused on measuring CYP2C19, Helicobacter pylori, non-variceal upper gastrointestinal bleeding, intragastric pH, proton pump inhibitor

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology and Internal Medicine, Medical University of Bialystok

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

omeprazole infusion (OI) group

omeprazole bolus (OB) group

Arm Description

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.

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.

Outcomes

Primary Outcome 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
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
intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection
intragastric pH profiles
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)
intragastric pH profiles

Secondary Outcome Measures

Full Information

First Posted
June 6, 2019
Last Updated
June 7, 2019
Sponsor
Medical University of Bialystok
Collaborators
National Science Centre, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT03980496
Brief Title
Effects of Different Omeprazole Dosing on Gastric pH in Non-variceal Upper Gastrointestinal Bleeding
Official Title
Effects of Different Omeprazole Dosing on Gastric pH in Non- Variceal Upper Gastrointestinal Bleeding: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2010 (Actual)
Primary Completion Date
June 8, 2013 (Actual)
Study Completion Date
June 8, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
Collaborators
National Science Centre, Poland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-variceal Upper Gastrointestinal Bleeding
Keywords
CYP2C19, Helicobacter pylori, non-variceal upper gastrointestinal bleeding, intragastric pH, proton pump inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omeprazole infusion (OI) group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
omeprazole bolus (OB) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
endoscopic treatment of non-variceal upper gastrointestinal bleeding
Primary Outcome Measure Information:
Title
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Percentage of time at pH >4.0 and pH >6.0
Description
intragastric pH profiles
Time Frame
72 hours
Title
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
Description
intragastric pH profiles
Time Frame
72 hours
Title
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection
Description
intragastric pH profiles
Time Frame
72 hours
Title
Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)
Description
intragastric pH profiles
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej Dabrowski, Prof.
Organizational Affiliation
Medical University of Bialystok
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology and Internal Medicine, Medical University of Bialystok
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27518195
Citation
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.
Results Reference
result

Learn more about this trial

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

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