Self Selection Trial of Naproxen Sodium

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.