Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 7:33 AM
Study NCT ID:
NCT01427803
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2011-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Actual Use Trial of Naproxen Sodium
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Kiefer AUT
Brief Summary:
An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: