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Study to Evaluate the Interaction Between Aspirin and Nexium

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01199328
First received: September 9, 2010
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: Aspirin
Drug: Esomeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin [ Time Frame: Ongoing throughout the study from consent through withdrawal ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199328

Locations
United States, Missouri
Research Site
Springfield, Missouri, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dennis N Morrison, MD Bio-Kinetic Clinical Applications
Study Director: Tore Lind AstraZeneca
Study Chair: Lynne Durborow AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MDS, AstraZeneca
ClinicalTrials.gov Identifier: NCT01199328     History of Changes
Other Study ID Numbers: D961FC00011
Study First Received: September 9, 2010
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Nexium
aspirin
peptic ulcers
pharmacodynamic (PD)
Esomoeprazole

Additional relevant MeSH terms:
Aspirin
Esomeprazole
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Proton Pump Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014