Actual Use Trial of Naproxen Sodium

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01427803

Run by

Bayer

People needed

778

Starts

2011-09-01

Expected to finish

2011-12-01

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 OTC analgesics for pain on at least 5 days in the last month
• Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
• 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
• Purchase the investigational product

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 NSAIDs (i.e., naproxen, ibuprofen, 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) are pregnant or breastfeeding

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — McCalla, Alabama, United States
• Study site — Pinson, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Oceanside, California, United States
• Study site — Yorba Linda, California, United States
• Study site — Overland Park, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Andover, Minnesota, United States
• Study site — Elk River, Minnesota, United States
• Study site — Fridley, Minnesota, United States
• Study site — Northfield, Minnesota, United States
• Study site — Rosemount, Minnesota, United States
• Study site — Roseville, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Saint Joseph, Missouri, United States
• Study site — Savannah, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Taos, New Mexico, United States
• Study site — Bountiful, Utah, United States
• Study site — Hurricane, Utah, United States
• Study site — Layton, Utah, United States
• Study site — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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