Self Selection Trial of Naproxen Sodium



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:July 2011
End Date:August 2011

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A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic

A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their
own use based on expected duration of pain greater than 12 hours.


Inclusion Criteria:

- At least 12 years of age

- Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the
past month

- Able to read and understand English

- Provide written informed consent (subjects 12-17 years of age provide written assent
and/or parent or legal guardian provide written consent)

- Provide contact information

Exclusion Criteria:

- Have participated in a trial involving OTC analgesics in the last 6 months

- They or someone else in the household work for a market research company, an
advertising agency, a public relations firm, a pharmaceutical company, as a
healthcare professional, or as part of a health care practice (eliminated for reasons
of confidentiality or increased awareness of drugs and their labels)

- Have a history of known allergies to Nonsteroidal Antiinflammatory Drugs (NSAIDs)
(i.e., naproxen, ibuprofen, acetaminophen, aspirin, etc.)

- Have a history of heart surgery in the last 60 days or plans for heart surgery in the
next 60 days

- Female subjects who have a positive urine pregnancy test or who are breastfeeding.
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