N/A
N=9
Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Aspirin Blood Level · Proton Pump Inhiditor Treatment
Bottom Line
View on ClinicalTrials.gov: NCT01061034 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Aspirin Level in Blood (Area Under the Curve) — 49.4; 50.7; 8.7; 6.5 mg*hour/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aspirin and omeprazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Assaf-Harofeh Medical Center
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aspirin Level in Blood (Area Under the Curve) |
49.4; 50.7; 8.7; 6.5 | — |
| SECONDARY Platelet Function Tests |
80; 8.55; 8.77 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01061034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.