Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
497 participants
INTERVENTIONAL
2008-07-31
2008-11-30
Brief Summary
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Detailed Description
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The following acronyms and abbreviations were used in the results section.
\- General Educational Development (GED)
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Naproxen Sodium ER (BAYH6689)
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
Naproxen Sodium ER (BAYH6689)
Consumer use of Extended Release Naproxen Sodium
Interventions
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Naproxen Sodium ER (BAYH6689)
Consumer use of Extended Release Naproxen Sodium
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Pegus Research, Inc.
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Anaheim, California, United States
Oceanside, California, United States
San Dimas, California, United States
Overland Park, Kansas, United States
Anoka, Minnesota, United States
Blaine, Minnesota, United States
Elk River, Minnesota, United States
Saint Francis, Minnesota, United States
Saint Louis Park, Minnesota, United States
Belton, Missouri, United States
Saint Joseph, Missouri, United States
Savannah, Missouri, United States
Cary, North Carolina, United States
Chapel Hill, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Syracuse, Utah, United States
West Jordan, Utah, United States
Kenmore, Washington, United States
Seattle, Washington, United States
Snohomish, Washington, United States
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2014-005268-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13129
Identifier Type: -
Identifier Source: org_study_id
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