Clinical Trial: Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

Brief Summary: The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of Participants With Any Serious Adverse Event [ Time Frame: 1 month ]

A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.


Original Primary Outcome: The number of adverse events in Japanese pediatric patients with chickenpox treated with valaciclovir [ Time Frame: 1 month at a maximum ]

Current Secondary Outcome:

  • Number of Participants With the Indicated Adverse Drug Reactions [ Time Frame: 1 month ]
    An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
  • Number of Participants With Any Unexpected Adverse Drug Reactions [ Time Frame: 1 month ]
    An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.
  • Number of Participants Classified as Effective and Not Effective [ Time Frame: 1 month ]
    The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. "Improved" was regarded as "Effective," and "Unchanged" and " Worsen" were regarded as "Not effective." The two participants classifed as "Not effective" were classified as "Unchanged."


Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: July 7, 2011
Date Started: November 2007
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017