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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.
ClinicalTrials.gov Identifier: NCT01094483
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : December 7, 2010
Sponsor:
Collaborator:
Information provided by:

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

Study Design

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
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01094483


Locations
United States, Kansas
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01094483     History of Changes
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:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics