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...
Date First Received: December 2, 2004
Last Updated: September 25, 2007
Verified by: Novartis, September 2007
Clinical Trial Phase: Phase 3 | Start Date: July 2005
Overall Status: Completed
Estimated Enrollment: 76
Brief Summary
Official Title: “Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: famciclovir
Outcome Measures for this Clinical Trial
Primary Measures
- Step A: Single-dose safety and pharmacokinetics
- Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary Measures
- Steps A & B: Acceptability of pediatric formulation by patients
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 12 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00098046
Study ID Number: CFAM810B2304
ClinicalTrials.gov Identifier: NCT00098046
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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