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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061034
First Posted: February 2, 2010
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

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.


Condition Intervention
Aspirin Blood Level Proton Pump Inhiditor Treatment Drug: aspirin and omeprazole

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Aspirin Level in Blood (Area Under the Curve) [ Time Frame: on day 7,on day 21 ]

Secondary Outcome Measures:
  • Platelet Function Tests [ Time Frame: on day 0 as a baseline and on day 7 and 21 of the study. ]

Enrollment: 9
Study Start Date: March 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aspirin and omeprazole
    aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01061034


Locations
Israel
Assaf Harofeh Medical Center
Zerifin, Israel
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Director: ahuva golik, prop. asaf-harofemedical center
  More Information

Responsible Party: dr. keren doenyas barak, internal medicine A asaf-harofeh medical center
ClinicalTrials.gov Identifier: NCT01061034     History of Changes
Other Study ID Numbers: 180/07
First Submitted: May 3, 2009
First Posted: February 2, 2010
Results First Submitted: May 3, 2009
Results First Posted: February 2, 2010
Last Update Posted: February 2, 2010
Last Verified: November 2009

Keywords provided by Assaf-Harofeh Medical Center:
pharmacokinetics
aspirin
proton pump inhiditor

Additional relevant MeSH terms:
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors