Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
NCT ID: NCT00098059
Last Updated: 2013-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2005-02-28
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Famciclovir, pediatric oral formulation
single-arm
Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Interventions
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Famciclovir
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Eligibility Criteria
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Inclusion Criteria
* Clinical evidence or suspicion of herpes simplex infection
Exclusion Criteria
* Concomitant use of probenecid
* Positive pregnancy test
1 Year
12 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
The Children's Hospital
Denver, Colorado, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Columbia University Medical Center
New York, New York, United States
State University of New York at
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
Panama Minister of Health
David, Chiriquí Province, Panama
Panama Minister of Health
Panama City, , Panama
Countries
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References
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Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9.
Other Identifiers
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CFAM810B2303
Identifier Type: -
Identifier Source: org_study_id
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