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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
  Purpose

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.


Condition Intervention Phase
Chickenpox
Herpes Zoster
Drug: famciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Step A: Single-dose safety and pharmacokinetics
  • Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days

Secondary Outcome Measures:
  • Steps A & B: Acceptability of pediatric formulation by patients

Estimated Enrollment: 76
Study Start Date: July 2005
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098046

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Costa Rica
Novartis Investigational Site
San Jose, Costa Rica
Guatemala
Novartis Investigational Site
Cuidad de Guatemala, Guatemala
Panama
Novartis Investigational Site
Ciudad de Panama, Panama
Novartis Investigational Site
David, Chiriqui, Panama
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00098046     History of Changes
Other Study ID Numbers: CFAM810B2304
Study First Received: December 2, 2004
Last Updated: September 25, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
chickenpox
herpes zoster
children
Famvir
varicella zoster virus

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Famciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014