NCT03980496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2013

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

June 6, 2019

Last Update Submit

June 7, 2019

Conditions

Non-variceal Upper Gastrointestinal Bleeding

Keywords

CYP2C19Helicobacter pylorinon-variceal upper gastrointestinal bleedingintragastric pHproton pump inhibitor

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: Helicobacter pylori infection

    intragastric pH profiles

    72 hours

  • Intragastric pH in non-variceal upper gastrointestinal bleeding patients treated with omeprazole regarding: CYP2C19 variant alleles (*2, *3, *17)

    intragastric pH profiles

    72 hours

Study Arms (2)

omeprazole infusion (OI) group

ACTIVE COMPARATOR

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

omeprazole bolus (OB) group

ACTIVE COMPARATOR

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

Interventions

OmeprazoleDRUG
Also known as: endoscopic treatment of non-variceal upper gastrointestinal bleeding
omeprazole bolus (OB) groupomeprazole infusion (OI) group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Internal Medicine, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Related 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 prospective study. J Dig Dis. 2016 Sep;17(9):588-599. doi: 10.1111/1751-2980.12393.

    PMID: 27518195RESULT

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Andrzej Dabrowski, Prof.

    Medical University of Bialystok

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 10, 2019

Study Start

September 9, 2010

Primary Completion

June 8, 2013

Study Completion

June 8, 2013

Last Updated

June 10, 2019

Record last verified: 2019-06

Locations

PL(1)