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

September 25, 2007 updated by: Novartis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
      • San Jose, Costa Rica
        • Novartis Investigational site
  • Guatemala
      • Cuidad de Guatemala, Guatemala
        • Novartis Investigational site
  • Panama
      • Ciudad de Panama, Panama
        • Novartis Investigational site
      • David, Chiriqui, Panama
        • Novartis Investigational site
  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Steps A & B: Acceptability of pediatric formulation by patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

December 2, 2004

First Submitted That Met QC Criteria

December 2, 2004

First Posted (Estimate)

December 3, 2004

Study Record Updates

Last Update Posted (Estimate)

September 26, 2007

Last Update Submitted That Met QC Criteria

September 25, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFAM810B2304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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