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Trial record 53 of 1254 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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Aspirin Blood Level
Proton Pump Inhiditor Treatment
Intervention Drug: aspirin and omeprazole
Enrollment 9
Recruitment Details healthy volunteers were recruted on march 2007. all of the patients are co-workers in the department of medicine in assaf harofeh medical center.
Pre-assignment Details one volunteer was excluded before enrollment due to recent consumption of NSAIDS
Arm/Group Title Aspirin Then Aspirin Plus Omeprazole
Hide Arm/Group Description 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Period Title: Aspirin
Started 9
Completed 9
Not Completed 0
Period Title: Aspirin Plus Omeprazole
Started 9
Completed 9
Not Completed 0
Arm/Group Title Aspirin Then Aspirin Plus Omeprazole
Hide Arm/Group Description 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
39.3  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
2
  22.2%
Male
7
  77.8%
1.Primary Outcome
Title Aspirin Level in Blood (Area Under the Curve)
Hide Description

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.

Time Frame on day 7,on day 21
Hide Outcome Measure Data
Hide Analysis Population Description
9 volunteers completed the study, one volunteer was excluded from pharmacokinetics, because serum salicylic acid concentration was not at the baseline (non-detectable) in the 0-hour sample.
Arm/Group Title Aspirin Then Aspirin Plus Omeprazole
Hide Arm/Group Description:
7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mg*hour/mL
aspirin area under the curve on day 7 49.4  (13.5)
aspirin area under the curve on day 21 50.7  (15.3)
1 hour after admission day 7 (aspirin alone) 8.7  (4)
1 hour after admission day 21 (aspirin+omeprazole) 6.5  (4.1)
2.Secondary Outcome
Title Platelet Function Tests
Hide Description

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.

Time Frame on day 0 as a baseline and on day 7 and 21 of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Then Aspirin Plus Omeprazole
Hide Arm/Group Description:
7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent
day 0 80  (4.18)
day 7 8.55  (2.45)
day 21 8.77  (2.38)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Then Aspirin Plus Omeprazole
Hide Arm/Group Description 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
All-Cause Mortality
Aspirin Then Aspirin Plus Omeprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Then Aspirin Plus Omeprazole
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin Then Aspirin Plus Omeprazole
Affected / at Risk (%)
Total   1/9 (11.11%) 
Gastrointestinal disorders   
mild dyspepsia  [1]  1/9 (11.11%) 
Indicates events were collected by systematic assessment
[1]
one volunteer complained mild dyspepsia unther aspirin treatment alone. his complaine resolved withoud any special intervention.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Keren Doenyas-Barak
Organization: Assaf Harofeh medical center
Phone: 972-57-7346651
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