Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection - Tabular View

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Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

This study has been completed.
Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Official Title ^†	A Multicenter, Open-Label, Single-Arm, Two-Step Study to Evaluate the Safety and Single-Dose Pharmacokinetics of Famciclovir and Multiple-Dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection
Brief Summary	Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famciclovir is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary Outcome Measure ^†	Step A: single-dose safety and pharmacokinetics Step B: safety/tolerability of pediatric oral formulation administered 2 times daily over 7 days
Secondary Outcome Measure ^†	Step A & B: acceptability of pediatric oral formulation by patients
Condition ^†	Herpes Simplex
Intervention ^†	Drug: Famvir (famciclovir)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	76
Start Date ^†	February 2005
Completion Date
Eligibility Criteria ^†	Inclusion Criteria: History or laboratory evidence of herpes simplex infection Clinical evidence or suspicion of herpes simplex infection Exclusion Criteria: Patients unable to swallow Concomitant use of probenecid Positive pregnancy test Additional protocol-defined inclusion/exclusion criteria may apply For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228
Gender	Both
Ages	1 Year to 12 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Guatemala, Panama

Administrative Information Fields
NCT ID ^†	NCT00098059
Organization ID	CFAM810B2303
Secondary IDs ^††
Study Sponsor ^†	Novartis
Collaborators ^††
Investigators ^†
Information Provided By	Novartis
Verification Date	September 2007
First Received Date ^†	December 2, 2004
Last Updated Date	December 7, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.