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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin and omeprazole | Drug | aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Aspirin Level in Blood (Area Under the Curve) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Function Tests | 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. |
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Inclusion Criteria:
-healthy volunteers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ahuva golik, prop. | asaf-harofemedical center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center | Ẕerifin | Israel |
one volunteer was excluded before enrollment due to recent consumption of NSAIDS
healthy volunteers were recruted on march 2007. all of the patients are co-workers in the department of medicine in assaf harofeh medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin Then Aspirin Plus Omeprazole | 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aspirin |
| |||||||||||||
| Aspirin Plus Omeprazole |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin Then Aspirin Plus Omeprazole | 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aspirin Level in Blood (Area Under the Curve) | 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. | 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. | Posted | Apr 2007 | Mean | Standard Deviation | mg*hour/mL | on day 7,on day 21 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin Then Aspirin Plus Omeprazole | 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild dyspepsia | Gastrointestinal disorders | Systematic Assessment | one volunteer complained mild dyspepsia unther aspirin treatment alone. his complaine resolved withoud any special intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keren Doenyas-Barak | Assaf Harofeh medical center | 972-57-7346651 | kerendoenyas@gmail.com |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Platelet Function Tests | 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. | Posted | Jan 2007 | Mean | Standard Deviation | percent | on day 0 as a baseline and on day 7 and 21 of the study. |
|
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|
| 0 |
| 9 |
| 1 |
| 9 |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|
|