Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers

January 2, 2010 updated by: Assaf-Harofeh Medical Center

The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.

Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.

We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.

healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.

All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.

Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.

Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

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

  • Israel
      • Zerifin, Israel
        • Assaf Harofeh Medical Center

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-healthy volunteers

Exclusion Criteria:

  • pretreatment with aspirin
  • pretreatment with non steroidal anti inflamatory drugs
  • pretreatment with antacids
  • history of peptic ulcer disease
  • coagulation or aggregation disorder.

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspirin Level in Blood (Area Under the Curve)
Time Frame: on day 7,on day 21

Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.

The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin.
on day 7,on day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Function Tests
Time Frame: on day 0 as a baseline and on day 7 and 21 of the study.

Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.

the results reflects the percent of active platelets.
on day 0 as a baseline and on day 7 and 21 of the study.

Collaborators and Investigators

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

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Director: ahuva golik, prop., asaf-harofemedical center

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

March 1, 2007

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

May 3, 2009

First Submitted That Met QC Criteria

January 2, 2010

First Posted (ESTIMATE)

February 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2010

Last Update Submitted That Met QC Criteria

January 2, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180/07

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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