Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
NCT ID: NCT01035346
Last Updated: 2012-08-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
16 participants
INTERVENTIONAL
2010-01-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Ibuprofen
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
B
Placebo
Single dose of a placebo
Interventions
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Ibuprofen
Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)
Placebo
Single dose of a placebo
Eligibility Criteria
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Inclusion Criteria
* Oral temperature measurement from 100 to 104 degrees Fahrenheit.
* Onset of fever 3 days or less.
* Otherwise good health.
Exclusion Criteria
* Currently taking antibiotics or antivirals.
* Currently taking any medication which may interfere with the assessment of fever.
* Pregnancy or breast-feeding.
* Any serious medical or psychiatric disorder.
12 Years
65 Years
ALL
No
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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Pfizer Investigational Site
Cypress, California, United States
Pfizer Investigational Site
Westlake Village, California, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Countries
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References
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Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
Related Links
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Other Identifiers
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AH-09-12
Identifier Type: -
Identifier Source: org_study_id