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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chickenpox; Herpes Zoster

Intervention: famciclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

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

Primary outcome:

Step A: Single-dose safety and pharmacokinetics

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

Secondary outcome: Steps A & B: Acceptability of pediatric formulation by patients

Eligibility

Minimum age: 1 Year. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigational Site, San Jose, Costa Rica

Novartis Investigational Site, Cuidad de Guatemala, Guatemala

Novartis Investigational Site, Ciudad de Panama, Panama

Novartis Investigational Site, David, Chiriqui, Panama

Columbia University Medical Center, New York, New York 10032, United States

Additional Information

Starting date: July 2005
Last updated: September 25, 2007

Page last updated: August 20, 2015

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