Actual Use Trial of Naproxen Sodium



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

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An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID

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.


Inclusion Criteria:

- 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

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 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
We found this trial at
32
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649
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Albuquerque, NM
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16
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Anaheim, CA
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Andover, MN
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Baltimore, MD
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959
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Bellevue, WA
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577
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Bountiful, UT
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Elk River, MN
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Fridley, MN
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Hoover, AL
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340
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Hurricane, UT
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1341
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Kansas City, MO
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970
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Kenmore, WA
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585
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Layton, UT
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1772
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McCalla, AL
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358
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Mesa, AZ
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Montpelier, VA
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Northfield, MN
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73
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Oceanside, CA
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592
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Ogden, UT
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1335
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Overland Park, KS
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Pinson, AL
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Richmond, VA
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Rosemount, MN
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Roseville, MN
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570
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Salt Lake City, UT
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Snohomish, WA
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1333
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St. Joseph, MO
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583
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Syracuse, UT
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727
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Taos, NM
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561
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West Jordan, UT
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17
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Yorba Linda, CA
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