Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
NCT ID: NCT01789606
Last Updated: 2017-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1083 participants
INTERVENTIONAL
2012-09-24
2013-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Interventions
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Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Eligibility Criteria
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Inclusion Criteria
* use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months
* provide written informed consent (subjects 12-\<18 years of age provide a written assent and parent/guardian will provide written informed consent)
* capable of and willing to swallow the study medication
Exclusion Criteria
* they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study
* have a history of known allergies to ibuprofen, aspirin, or other NSAIDs
* have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days
* female subjects are pregnant or breast feeding
12 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Medical Arts Rexall Pharmacy
Anaheim, California, United States
B and B Pharmacy
Yorba Linda, California, United States
Wynn's Pharmacy Inc.
Griffin, Georgia, United States
Stark Pharmacy
Overland Park, Kansas, United States
Catonsville Pharmacy
Baltimore, Maryland, United States
Goodrich Pharmacy
Blaine, Minnesota, United States
Kemper Drug
Elk River, Minnesota, United States
Cub Pharmacy Number 1924
Saint Louis Park, Minnesota, United States
Albers' Medical Pharmacy
Kansas City, Missouri, United States
Countryside Pharmacy
Savannah, Missouri, United States
Duran Central Pharmacy
Albuquerque, New Mexico, United States
Total Health and Wellness Center of Taos
Taos, New Mexico, United States
The Medicine Shoppe
Ogden, Utah, United States
The Medicine Shoppe
Salt Lake City, Utah, United States
Family Plaza Pharmacy
West Jordan, Utah, United States
Montpelier Pharmacy, Inc.
Montpelier, Virginia, United States
Ostrom Drugs
Kenmore, Washington, United States
Kusler's Pharmacy
Snohomish, Washington, United States
Countries
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References
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Paluch E, Jayawardena S, Wilson B, Farnsworth S. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):397-404. doi: 10.1016/j.japh.2016.03.003. Epub 2016 May 13.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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AK-10-11
Identifier Type: OTHER
Identifier Source: secondary_id
B4371008
Identifier Type: -
Identifier Source: org_study_id
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