Clinical Trial: Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Brief 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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome:
- Step A: Single-dose safety and pharmacokinetics
- Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Original Primary Outcome:
- Safety
- Blood levels
Current Secondary Outcome: Steps A & B: Acceptability of pediatric formulation by patients
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: December 2, 2004
Date Started: July 2005
Date Completion:
Last Updated: September 25, 2007
Last Verified: September 2007
