Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2008-02-29
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexibuprofen 1
Dexibuprofen 2.5 or 5 mg/kg
Dexibuprofen
one dose of Dexibuprofen 2.5 or 5 mg/kg
Dexibuprofen 2
Dexibuprofen 3.5 or 7 mg/kg
Dexibuprofen
one dose of Dexibuprofen 3.5 or 7 mg/kg
Ibuprofen
Ibuprofen 5 or 10 mg/kg
Ibuprofen
one dose of Ibuprofen 5 or 10 mg/kg
Interventions
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Dexibuprofen
one dose of Dexibuprofen 2.5 or 5 mg/kg
Dexibuprofen
one dose of Dexibuprofen 3.5 or 7 mg/kg
Ibuprofen
one dose of Ibuprofen 5 or 10 mg/kg
Eligibility Criteria
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Inclusion Criteria
* Age 6 months to 14 years
Exclusion Criteria
* Bleeding tendency
* Liver disease
* Kidney disease
* Hypertension
* Hypersensitivity to the drug
6 Months
14 Years
ALL
No
Sponsors
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Inje University
OTHER
Responsible Party
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Inje University Sanggye Paik Hospital
Principal Investigators
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Young Yull Koh
Role: STUDY_DIRECTOR
Seoul National University Hospital
Chang-Keun Kim
Role: PRINCIPAL_INVESTIGATOR
Inje University
Locations
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Asan Medical Center
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Korea University Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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AG_DIBU_2007
Identifier Type: -
Identifier Source: org_study_id
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