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Trial record 3 of 88 for:    ASPIRIN AND thromboxane

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01094483
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : December 7, 2010
Information provided by:

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
Platelet Inhibition Drug: PN400 Drug: ASA Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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 Name: Asprin

Placebo Comparator: 2
Placebo + ASA
Drug: ASA
Asprin 81 mg enteric coated tablet
Other Name: Asprin

Drug: Placebo

Primary Outcome Measures :
  1. 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 ]
  2. Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events [ Time Frame: during approx 6 week study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01094483

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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
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Principal Investigator: Ralph Schutz, MD Quintiles Phase 1 Services
Study Director: Catherine Datto, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MSD, AstraZeneca Identifier: NCT01094483    
Other Study ID Numbers: D1120C00036
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
Thromboxane B2
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors