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

This study has been completed.
Sponsor:
Collaborator:
POZEN
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01094483
First received: March 25, 2010
Last updated: December 6, 2010
Last verified: December 2010
History of Changes

March 25, 2010
December 6, 2010
March 2010
May 2010   (final data collection date for primary outcome measure)
  • Pharmacodynamic: Mean percent inhibition of serum thromboxane B2 [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events [ Time Frame: during approx 6 week study period ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01094483 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin
A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Platelet Inhibition
  • Drug: PN400
    naproxen 500 mg/esomeprazole 20 mg oral tablet
  • Drug: ASA
    Asprin 81 mg enteric coated tablet
    Other Name: Asprin
  • Drug: Placebo
  • Experimental: 1
    PN400 + ASA
    Interventions:
    • Drug: PN400
    • Drug: ASA
  • Placebo Comparator: 2
    Placebo + ASA
    Interventions:
    • Drug: ASA
    • Drug: Placebo
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. Epub 2011 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stable without clinically significant disease

Exclusion Criteria:

  • Use of NSAID within 2 weeks
  • Type 1 or 2 DM
  • GI disorder
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01094483
D1120C00036
Not Provided
MSD, AstraZeneca
AstraZeneca
POZEN
Principal Investigator: Ralph Schutz, MD Quintiles Phase 1 Services
Study Director: Catherine Datto, MD AstraZeneca
AstraZeneca
December 2010

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