Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
778 participants
INTERVENTIONAL
2011-09-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain
Interventions
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Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
Yes
Sponsors
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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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Hoover, Alabama, United States
McCalla, Alabama, United States
Pinson, Alabama, United States
Mesa, Arizona, United States
Anaheim, California, United States
Oceanside, California, United States
Yorba Linda, California, United States
Overland Park, Kansas, United States
Baltimore, Maryland, United States
Andover, Minnesota, United States
Elk River, Minnesota, United States
Fridley, Minnesota, United States
Northfield, Minnesota, United States
Rosemount, Minnesota, United States
Roseville, Minnesota, United States
Kansas City, Missouri, United States
Saint Joseph, Missouri, United States
Savannah, Missouri, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Taos, New Mexico, United States
Bountiful, Utah, United States
Hurricane, Utah, United States
Layton, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Syracuse, Utah, United States
West Jordan, Utah, United States
Montpelier, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Kenmore, Washington, United States
Snohomish, Washington, United States
Countries
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Other Identifiers
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15647
Identifier Type: -
Identifier Source: org_study_id
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