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Completed

NCT Number: NCT00098046

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.

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Key information

Conditions

Chickenpox DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigational Site, San José, Costa Rica

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Famciclovir

Drug

Primary outcomes

  1. Step A: Single-dose safety and pharmacokinetics

  2. Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days

Secondary outcomes

  1. Steps A & B: Acceptability of pediatric formulation by patients

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Dec 3, 2004
Registry last updated
Sep 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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