Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chickenpox; Herpes Zoster
Intervention: famciclovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals
Summary
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is
usually a self-limiting illness characterized by fever and a rash. Serious complications
can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral
treatment is not a standard of care in immunocompetent children, but is recommended whenever
a risk of complication exists. This study will evaluate the safety and blood levels of a new
formulation of famciclovir in children 1-12 years of age.
Clinical Details
Official title: Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Step A: Single-dose safety and pharmacokineticsStep B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary outcome: Steps A & B: Acceptability of pediatric formulation by patients
Eligibility
Minimum age: 1 Year.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female children 1-12 years of age
- Clinical or laboratory evidence of varicella zoster infection
- Patients suspected of having varicella zoster infection
Exclusion Criteria:
- Patients unable to swallow
- Concomitant use of probenecid
- Positive pregnancy
Additional protocol-defined inclusion/exclusion criterial may apply. For detailed
information on eligibility, please contact the study center nearest to you (see below), or
call the following number 1-862-778-3544 or 1-434-951-3228
Locations and Contacts
Novartis Investigational Site, San Jose, Costa Rica
Novartis Investigational Site, Cuidad de Guatemala, Guatemala
Novartis Investigational Site, Ciudad de Panama, Panama
Novartis Investigational Site, David, Chiriqui, Panama
Columbia University Medical Center, New York, New York 10032, United States
Additional Information
Starting date: July 2005
Last updated: September 25, 2007
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