POZN (11.12) some additional safety data trial info below currently going on with PN400 (VIMOVO) for your reading. Might be for a possible future OTC version but not sure. I dont see this effecting the FDA decision because they know the effects of aspirin and naproxen but it could effect labeling possibly.
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin
This study is currently recruiting participants.
Verified by AstraZeneca, March 2010
First Received: March 25, 2010 Last Updated: March 26, 2010 History of Changes
Sponsor: AstraZeneca
Collaborator: POZEN
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT01094483
Purpose
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 Intervention Phase
Platelet Inhibition
Drug: PN400
Drug: ASA
Drug: Placebo
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
* 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 ]
Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
PN400 + ASA
Drug: PN400
naproxen 500 mg/esomeprazole 20 mg oral tablet
Drug: ASA
Asprin 81 mg enteric coated tablet
2: Placebo Comparator
Placebo + ASA
Drug: ASA
Asprin 81 mg enteric coated tablet
Drug: Placebo
Eligibility
Ages Eligible for Study: 50 Years to 75 Years
Genders Eligible for Study: Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094483
Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com
Locations
United States, Kansas
Research Site Recruiting
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
No publications provided
Responsible Party: AstraZeneca ( MSD )
Study ID Numbers: D1120C00036
Study First Received: March 25, 2010
Last Updated: March 26, 2010
ClinicalTrials.gov Identifier: NCT01094483 History of Changes
Health Authority: United States: Food and Drug Administration
Keywords provided by AstraZeneca:
Thromboxane B2
ClinicalTrials.gov processed this record on April 25, 2010
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