NCT01094483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

March 25, 2010

Last Update Submit

December 6, 2010

Conditions

Platelet Inhibition

Keywords

Thromboxane B2

Outcome Measures

Primary Outcomes (2)

  • 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

  • Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events

    during approx 6 week study period

Study Arms (2)

1

EXPERIMENTAL

PN400 + ASA

Drug: PN400Drug: ASA

2

PLACEBO COMPARATOR

Placebo + ASA

Drug: ASADrug: Placebo

Interventions

PN400DRUG

naproxen 500 mg/esomeprazole 20 mg oral tablet

1
ASADRUG

Asprin 81 mg enteric coated tablet

Also known as: Asprin
12
PlaceboDRUG
2

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable without clinically significant disease

You may not qualify if:

  • Use of NSAID within 2 weeks
  • Type 1 or 2 DM
  • GI disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • 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.

    PMID: 22078153DERIVED

MeSH Terms

Interventions

acetylsalicylic acid lysinate

Study Officials

  • Ralph Schutz, MD

    Quintiles Phase 1 Services

    PRINCIPAL INVESTIGATOR

  • Catherine Datto, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

US(1)