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Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

This study has been completed.
Information provided by Novartis

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Descriptive Information Fields
Brief Title  Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Official Title  A Multicenter, Open-Label, Single-Arm, Two-Step Study to Evaluate the Safety and Single-Dose Pharmacokinetics of Famciclovir and Multiple-Dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection
Brief Summary

Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famciclovir is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary Outcome Measure  Step A: single-dose safety and pharmacokinetics
Step B: safety/tolerability of pediatric oral formulation administered 2 times daily over 7 days
Secondary Outcome Measure  Step A & B: acceptability of pediatric oral formulation by patients
Condition  Herpes Simplex
Intervention  Drug: Famvir (famciclovir)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  76
Start Date  February 2005
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • History or laboratory evidence of herpes simplex infection
  • Clinical evidence or suspicion of herpes simplex infection

Exclusion Criteria:

  • Patients unable to swallow
  • Concomitant use of probenecid
  • Positive pregnancy test

Additional protocol-defined inclusion/exclusion criteria may apply For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228

Gender Both
Ages 1 Year to 12 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Guatemala,   Panama
Administrative Information Fields
NCT ID  NCT00098059
Organization ID CFAM810B2303
Secondary IDs ††
Study Sponsor  Novartis
Collaborators ††
Investigators 
Information Provided By Novartis
Verification Date September 2007
First Received Date  December 2, 2004
Last Updated Date December 7, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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