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Study to Evaluate the Interaction Between Aspirin and Nexium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199328
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 19, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Aspirin Drug: Esomeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open, Two-way Crossover, Drug-drug Interaction Study Evaluating the Effect of Esomeprazole on the Pharmacodynamics of Acetylsalicylic Acid After 5 Days of Treatment
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Active Comparator: 1
Aspirin 81 mg
Drug: Aspirin
81mg Tablet oral, once daily

Active Comparator: 2
Esomeprazole 20mg/aspirin 81mg
Drug: Aspirin
81mg Tablet oral, once daily

Drug: Esomeprazole
20 mg Tablet oral, once daily
Other Name: Nexium

Primary Outcome Measures :
  1. Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers [ Time Frame: Ongoing throughout the study from consent through withdrawal ]

Secondary Outcome Measures :
  1. Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline [ Time Frame: Ongoing throughout the study from consent through withdrawal ]
  2. Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin [ Time Frame: Ongoing throughout the study from consent through withdrawal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199328

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United States, Missouri
Research Site
Springfield, Missouri, United States
Sponsors and Collaborators
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Principal Investigator: Dennis N Morrison, MD Bio-Kinetic Clinical Applications
Study Director: Tore Lind AstraZeneca
Study Chair: Lynne Durborow AstraZeneca
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MDS, AstraZeneca Identifier: NCT01199328    
Other Study ID Numbers: D961FC00011
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Keywords provided by AstraZeneca:
peptic ulcers
pharmacodynamic (PD)
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors