Trial Outcomes & Findings for Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers (NCT NCT01061034)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

on day 7,on day 21

Results posted on

2010-02-02

Participant Flow

healthy volunteers were recruted on march 2007. all of the patients are co-workers in the department of medicine in assaf harofeh medical center.

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

Participant milestones

Participant milestones
Measure	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
Aspirin STARTED	9
Aspirin COMPLETED	9
Aspirin NOT COMPLETED	0
Aspirin Plus Omeprazole STARTED	9
Aspirin Plus Omeprazole COMPLETED	9
Aspirin Plus Omeprazole NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin Then Aspirin Plus Omeprazole n=9 Participants 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	39.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: on day 7,on day 21

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Aspirin Then Aspirin Plus Omeprazole n=8 Participants 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Aspirin Level in Blood (Area Under the Curve) aspirin area under the curve on day 7	49.4 mg*hour/mL Standard Deviation 13.5
Aspirin Level in Blood (Area Under the Curve) aspirin area under the curve on day 21	50.7 mg*hour/mL Standard Deviation 15.3
Aspirin Level in Blood (Area Under the Curve) 1 hour after admission day 7 (aspirin alone)	8.7 mg*hour/mL Standard Deviation 4
Aspirin Level in Blood (Area Under the Curve) 1 hour after admission day 21 (aspirin+omeprazole)	6.5 mg*hour/mL Standard Deviation 4.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aspirin Then Aspirin Plus Omeprazole n=9 Participants 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Platelet Function Tests day 0	80 percent Standard Deviation 4.18
Platelet Function Tests day 7	8.55 percent Standard Deviation 2.45
Platelet Function Tests day 21	8.77 percent Standard Deviation 2.38

Adverse Events

Aspirin Then Aspirin Plus Omeprazole

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aspirin Then Aspirin Plus Omeprazole n=9 participants at risk 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Gastrointestinal disorders mild dyspepsia	11.1% 1/9

Additional Information

Dr. Keren Doenyas-Barak

Assaf Harofeh medical center

Phone: 972-57-7346651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place