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Study to Evaluate the Interaction Between Aspirin and Nexium

NCT ID: NCT01199328

Last Updated: 2010-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Nexium aspirin peptic ulcers pharmacodynamic (PD) Esomoeprazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Aspirin 81 mg

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

81mg Tablet oral, once daily

2

Esomeprazole 20mg/aspirin 81mg

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

81mg Tablet oral, once daily

Esomeprazole

Intervention Type DRUG

20 mg Tablet oral, once daily

Interventions

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Aspirin

81mg Tablet oral, once daily

Intervention Type DRUG

Esomeprazole

20 mg Tablet oral, once daily

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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Inclusion Criteria

* Provision informed consent prior to any study specific procedures.
* Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture.
* Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control:
* Continuously practice abstinence during screening and throughout the duration of the study
* Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives.
* Have a body mass index (BMI) between 19 and 30 kg/m2
* No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria

* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
* Previous enrolment or randomisation in the present study.
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease
* History or presence of clinically significant gastrointestinal e.e. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
* Any clinically significant illness within 4 weeks of the first administration of investigational product.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Dennis N Morrison, MD

Role: PRINCIPAL_INVESTIGATOR

Bio-Kinetic Clinical Applications

Tore Lind

Role: STUDY_DIRECTOR

AstraZeneca

Lynne Durborow

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Springfield, Missouri, United States

Site Status

Countries

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United States

References

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Andersson T, Morrison D, Nagy P, Pisupati J, Schettler J, Warner TD. Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):217-24. doi: 10.1007/BF03261830.

Reference Type DERIVED
PMID: 22631032 (View on PubMed)

Other Identifiers

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D961FC00011

Identifier Type: -

Identifier Source: org_study_id