Clinical Trials Directory

Trials / Completed

CompletedNCT00098046

Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
76 (estimated)
Sponsor
Novartis · Industry
Sex
All
Age
1 Year – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGfamciclovir

Timeline

Start date
2005-07-01
Completion
2007-07-01
First posted
2004-12-03
Last updated
2007-09-26

Locations

5 sites across 4 countries: United States, Costa Rica, Guatemala, Panama

Source: ClinicalTrials.gov record NCT00098046. Inclusion in this directory is not an endorsement.