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

NCT ID: NCT01094483

Last Updated: 2010-12-07

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Platelet Inhibition

Keywords

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Thromboxane B2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

PN400 + ASA

Group Type EXPERIMENTAL

PN400

Intervention Type DRUG

naproxen 500 mg/esomeprazole 20 mg oral tablet

ASA

Intervention Type DRUG

Asprin 81 mg enteric coated tablet

2

Placebo + ASA

Group Type PLACEBO_COMPARATOR

ASA

Intervention Type DRUG

Asprin 81 mg enteric coated tablet

Placebo

Intervention Type DRUG

Interventions

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PN400

naproxen 500 mg/esomeprazole 20 mg oral tablet

Intervention Type DRUG

ASA

Asprin 81 mg enteric coated tablet

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Asprin

Eligibility Criteria

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Inclusion Criteria

* Stable without clinically significant disease

Exclusion Criteria

* Use of NSAID within 2 weeks
* Type 1 or 2 DM
* GI disorder
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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POZEN

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Ralph Schutz, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase 1 Services

Catherine Datto, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

References

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Angiolillo DJ, Hwang C, Datto C, Desai B, Sostek M. Impact of a fixed-dose combination of naproxen and esomeprazole magnesium on serum thromboxane B2 inhibition by low-dose aspirin over 5 days in healthy adults: a phase I, randomized, double-blind, placebo-controlled, noninferiority trial. Clin Ther. 2011 Dec;33(12):1883-93. doi: 10.1016/j.clinthera.2011.10.009. Epub 2011 Nov 10.

Reference Type DERIVED
PMID: 22078153 (View on PubMed)

Other Identifiers

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D1120C00036

Identifier Type: -

Identifier Source: org_study_id