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A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01094483
Collaborator
POZEN (Industry)
40
Enrollment
1
Location
2
Arms
2
Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Official Title:
A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

PN400 + ASA

Drug: PN400
naproxen 500 mg/esomeprazole 20 mg oral tablet

Drug: ASA
Asprin 81 mg enteric coated tablet
Other Names:
  • Asprin

    		•
    Placebo Comparator: 2

    Placebo + ASA

    Drug: ASA
    Asprin 81 mg enteric coated tablet
    Other Names:
  • Asprin

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacodynamic: Mean percent inhibition of serum thromboxane B2 [measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2]

    2. Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events [during approx 6 week study period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Stable without clinically significant disease
    Exclusion Criteria:

    • Use of NSAID within 2 weeks

    • Type 1 or 2 DM

    • GI disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Overland Park Kansas United States

    Sponsors and Collaborators

    • AstraZeneca
    • POZEN

    Investigators

    • Principal Investigator: Ralph Schutz, MD, Quintiles Phase 1 Services
    • Study Director: Catherine Datto, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01094483
    Other Study ID Numbers:
    • D1120C00036
    First Posted:
    Mar 29, 2010
    Last Update Posted:
    Dec 7, 2010
    Last Verified:
    Dec 1, 2010
    Keywords provided by , ,
    Thromboxane B2

    Study Results

    No Results Posted as of Dec 7, 2010