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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.
 
ClinicalTrials.gov Identifier: NCT01199328
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date November 19, 2010
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • 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 ]
  • Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin [ Time Frame: Ongoing throughout the study from consent through withdrawal ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Interaction Between Aspirin and Nexium
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Aspirin
    81mg Tablet oral, once daily
  • Drug: Esomeprazole
    20 mg Tablet oral, once daily
    Other Name: Nexium
Study Arms  ICMJE
  • Active Comparator: 1
    Aspirin 81 mg
    Intervention: Drug: Aspirin
  • Active Comparator: 2
    Esomeprazole 20mg/aspirin 81mg
    Interventions:
    • Drug: Aspirin
    • Drug: Esomeprazole
Publications * 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: 10.2165/11634280-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2010)
34
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
35
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01199328
Other Study ID Numbers  ICMJE D961FC00011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MDS, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis N Morrison, MD Bio-Kinetic Clinical Applications
Study Director: Tore Lind AstraZeneca
Study Chair: Lynne Durborow AstraZeneca
PRS Account AstraZeneca
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP