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Trial record 55 of 1302 for:    ASPIRIN AND Platelet Aggregation

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

Tracking Information
First Submitted Date  ICMJE May 3, 2009
First Posted Date  ICMJE February 2, 2010
Results First Submitted Date  ICMJE May 3, 2009
Results First Posted Date  ICMJE February 2, 2010
Last Update Posted Date February 2, 2010
Study Start Date  ICMJE March 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2010)
Aspirin Level in Blood (Area Under the Curve) [ Time Frame: on day 7,on day 21 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2010)
Platelet Function Tests [ Time Frame: on day 0 as a baseline and on day 7 and 21 of the study. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Official Title  ICMJE The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Aspirin Blood Level
  • Proton Pump Inhiditor Treatment
Intervention  ICMJE Drug: aspirin and omeprazole
aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2010)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01061034
Other Study ID Numbers  ICMJE 180/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party dr. keren doenyas barak, internal medicine A asaf-harofeh medical center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ahuva golik, prop. asaf-harofemedical center
PRS Account Assaf-Harofeh Medical Center
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP