Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00098046
First received: December 2, 2004
Last updated: September 25, 2007
Last verified: September 2007

December 2, 2004
September 25, 2007
July 2005
Not Provided
  • Step A: Single-dose safety and pharmacokinetics
  • Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
  • Safety
  • Blood levels
Complete list of historical versions of study NCT00098046 on ClinicalTrials.gov Archive Site
Steps A & B: Acceptability of pediatric formulation by patients
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chickenpox
  • Herpes Zoster
Drug: famciclovir
Not Provided
Sáez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De León Castrejón T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. Epub 2009 Mar 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
July 2007
Not Provided

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

Both
1 Year to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Costa Rica,   Guatemala,   Panama
 
NCT00098046
CFAM810B2304
Not Provided
Not Provided
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP