Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Aspirin Blood Level Proton Pump Inhiditor Treatment |
Drug: aspirin and omeprazole |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption. |
- Aspirin Level in Blood (Area Under the Curve) [ Time Frame: on day 7,on day 21 ] [ Designated as safety issue: No ]
- Platelet Function Tests [ Time Frame: on day 0 as a baseline and on day 7 and 21 of the study. ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
-
Drug: aspirin and omeprazole
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| 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 |
| Study First Received: | May 3, 2009 |
| Results First Received: | May 3, 2009 |
| Last Updated: | January 2, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Assaf-Harofeh Medical Center:
|
pharmacokinetics aspirin proton pump inhiditor |
Additional relevant MeSH terms:
|
Aspirin Omeprazole Proton Pump Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Anti-Ulcer Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013