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

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ClinicalTrials.gov Identifier: NCT01061034
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : February 2, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Aspirin Blood Level Proton Pump Inhiditor Treatment Drug: aspirin and omeprazole Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
Study Start Date : March 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: aspirin and omeprazole
    aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.


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

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


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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.

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

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 Posted: February 2, 2010    Key Record Dates
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