Aspirin Blood LevelNCT01061034

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

A study testing aspirin and omeprazole in people with Aspirin Blood Level and Proton Pump Inhiditor Treatment, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Aspirin Blood Level, Proton Pump Inhiditor Treatment
What is being tested?: aspirin and omeprazole
How many people: 9 participants
Where: 1 siteIsrael
Study dates: Mar 2007to Jun 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

-healthy volunteers

Who cannot join

pretreatment with aspirin
pretreatment with non steroidal anti inflamatory drugs
pretreatment with antacids
history of peptic ulcer disease
coagulation or aggregation disorder.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Assaf Harofeh Medical Center
Tsrifin

Other trials in Israel

About this study

Official title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.

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.

Conditions: Aspirin Blood Level, Proton Pump Inhiditor Treatment
Being tested: aspirin and omeprazole
Keywords: pharmacokinetics, aspirin, proton pump inhiditor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aspirin and omeprazoleDrug
aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: on day 7,on day 21

Secondary outcomes (1)

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.
Measured: on day 0 as a baseline and on day 7 and 21 of the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jun 2007

First posted2 Feb 2010 (estimated)
Study startMar 2007
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aspirin Blood LevelStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01061034
Sponsor's protocol ID: 180/07
Status last verified: Nov 2009
First submitted: 3 May 2009
Last updated: 2 Feb 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
ClinicalTrials.gov ID: NCT01061034
Acronym / sponsor ID: 180/07
Conditions: Aspirin Blood Level, Proton Pump Inhiditor Treatment
Keywords: pharmacokinetics, aspirin, proton pump inhiditor
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Assaf-Harofeh Medical CenterOther government
Study start: Mar 2007
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 2 Feb 2010 (estimated)
Results: Posted 2 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

-healthy volunteers

Key exclusion criteria (5 listed)

pretreatment with aspirin
pretreatment with non steroidal anti inflamatory drugs
pretreatment with antacids
history of peptic ulcer disease
coagulation or aggregation disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aspirin and omeprazoleaspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.	Drug	–

Primary outcome

Aspirin Level in Blood (Area Under the Curve)
Time frame: 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.

1 secondary outcome

Platelet Function Tests
Time frame: on day 0 as a baseline and on day 7 and 21 of the study.

Results and safety

Results posted to the registry on 2 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aspirin Then Aspirin Plus Omeprazole	9	9

Primary outcome: Aspirin Level in Blood (Area Under the Curve)

Time frame: on day 7,on day 21. Mean (Standard Deviation). Unit: mg*hour/mL

Measure	Aspirin Then Aspirin Plus Omeprazole n = 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)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin Then Aspirin Plus Omeprazole	0 of 9 (0%)	1 of 9 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ahuva golik, prop. study director

asaf-harofemedical center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing aspirin and omeprazole in people with Aspirin Blood Level and Proton Pump Inhiditor Treatment, run by Assaf-Harofeh Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aspirin Level in Blood (Area Under the Curve) (time frame: on day 7,on day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.