Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01061034
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspirin Blood Level; Proton Pump Inhiditor Treatment	Drug: aspirin and omeprazole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Aspirin Level in Blood (Area Under the Curve) [on day 7,on day 21]

   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.

Secondary Outcome Measures

1. Platelet Function Tests [on day 0 as a baseline and on day 7 and 21 of the study.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Assaf Harofeh Medical Center	Zerifin		Israel

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

• Study Director: ahuva golik, prop., asaf-harofemedical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01061034
• Other Study ID Numbers: 180/07
• First Posted: Feb 2, 2010
• Last Update Posted: Feb 2, 2010
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: pharmacokinetics; aspirin; proton pump inhiditor
• Additional relevant MeSH terms: Aspirin; Omeprazole

Study Results

Participant Flow

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 Detail	one volunteer was excluded before enrollment due to recent consumption of NSAIDS

Arm/Group Title	Aspirin Then Aspirin Plus Omeprazole
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
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Aspirin Then Aspirin Plus Omeprazole
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 Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.3 (12.5)
Sex: Female, Male (Count of Participants)
Female	2 22.2%
Male	7 77.8%

Outcome Measures

1. Primary Outcome

Title	Aspirin Level in Blood (Area Under the Curve)
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

Outcome Measure Data

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
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
Measure Participants	8
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
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aspirin Then Aspirin Plus Omeprazole
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
Measure Participants	9
day 0	80 (4.18)
day 7	8.55 (2.45)
day 21	8.77 (2.38)

Adverse Events

Arm/Group Title	Aspirin Then Aspirin Plus Omeprazole
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Aspirin Then Aspirin Plus Omeprazole
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Aspirin Then Aspirin Plus Omeprazole
	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)
Gastrointestinal disorders
mild dyspepsia	1/9 (11.1%)

Limitations/Caveats

[Not Specified]

More Information

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.