Self Selection Trial of Naproxen Sodium

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01383486

Run by

Bayer

People needed

253

Starts

2011-07-01

Expected to finish

2011-08-01

Last updated by the study team

2015-10-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Yorba Linda, California, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Griffin, Georgia, United States
• Study site — Andover, Minnesota, United States
• Study site — Roseville, Minnesota, United States
• Study site — Bountiful, Utah, United States
• Study site — West Jordan, Utah, United States
• Study site — Bellevue, Washington, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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