Naproxen Sodium Extended-Release Actual Use Study

Completed · Phase 3

Conditions studied: Pain

In brief

The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Key facts

Study ID

NCT00751400

Run by

Bayer

People needed

497

Starts

2008-07-01

Expected to finish

2008-11-01

Last updated by the study team

2015-08-25

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Self report use of Over The Counter (OTC) analgesics
• Able to read and understand English
• Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent)
• Purchase the investigational product

You may not qualify if…

• Have participated in a study involving OTC analgesics in the last 12 months
• They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice
• Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin
• 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 — Anaheim, California, United States
• Study site — Oceanside, California, United States
• Study site — San Dimas, California, United States
• Study site — Overland Park, Kansas, United States
• Study site — Anoka, Minnesota, United States
• Study site — Blaine, Minnesota, United States
• Study site — Elk River, Minnesota, United States
• Study site — Saint Francis, Minnesota, United States
• Study site — Saint Louis Park, Minnesota, United States
• Study site — Belton, Missouri, United States
• Study site — Saint Joseph, Missouri, United States
• Study site — Savannah, Missouri, United States
• Study site — Cary, North Carolina, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Bountiful, Utah, United States
• Study site — Ogden, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Syracuse, Utah, United States
• Study site — West Jordan, Utah, United States
• Study site — Kenmore, Washington, United States
• Study site — Seattle, Washington, United States
• Study site — Snohomish, Washington, United States

Full record on ClinicalTrials.gov

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