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

Non-variceal Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980496
• Other study ID #: N N402 462539
• Secondary ID: 4625/B/P01/2010/
• Status: Completed
• Phase: Phase 4
• Start date: September 9, 2010
• Est. completion date: June 8, 2013

Study information

• Verified date: June 2019
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 8, 2013
• Est. primary completion date: June 8, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Non-variceal Upper Gastrointestinal Bleeding

Intervention

Drug:
• Omeprazole

Locations

Country	Name	City	State
Poland	Department of Gastroenterology and Internal Medicine, Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Bialystok	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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 prosp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours
Primary	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	72 hours
Primary	Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection	intragastric pH profiles	72 hours
Primary	Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)	intragastric pH profiles	72 hours

External Links

•   J Dig Dis. 2016 Sep;17(9):588-599