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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098046
• Other study ID #: CFAM810B2304
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2004
• Last updated: September 25, 2007
• Start date: July 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster

Intervention

Drug:
• famciclovir

Locations

Country	Name	City	State
Costa Rica	Novartis Investigational Site	San Jose
Guatemala	Novartis Investigational Site	Cuidad de Guatemala
Panama	Novartis Investigational Site	Ciudad de Panama
Panama	Novartis Investigational Site	David, Chiriqui
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Costa Rica,  Guatemala,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step A: Single-dose safety and pharmacokinetics
Primary	Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary	Steps A & B: Acceptability of pediatric formulation by patients