Last updated: 11/07/2018 04:43:12

Special Drug Use Investigation for VALTREX (valaciclovir) (Pediatrics Chickenpox)

GSK study ID
112323
See study documents
Clinicaltrials.gov ID
NCT01390857
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Special Drug Use Investigation for VALTREX (valaciclovir) (Pediatrics Chickenpox)
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with any serious adverse event

Timeframe: 1 month

Secondary outcomes:

Number of participants with the indicated adverse drug reactions

Timeframe: 1 month

Number of participants with any unexpected adverse drug reactions

Timeframe: 1 month

Number of participants classified as effective and not effective

Timeframe: 1 month

Interventions:
  • Drug: Valaciclovir
    • Enrollment:
    379
    Primary completion date:
    2011-28-02
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Hiroharu Abe, Hideyuki Okano, Terufumi Hara, Pascal Yoshida. Report on Results of Post-marketing Surveillance for Valaciclovir Hydrochloride (Valtrex®) ~ from Special Drug Use Investigation in Pediatric Patients with Chickenpox ~. J Clin Therapeut Med. 2012;28(12):1193-1203.
    Medical condition
    Varicella
    Product
    valaciclovir
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to February 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable N/A - 14 years
    Accepts healthy volunteers
    No
    • Pediatric patients with chickenpox (aged less than 15 years old).
    • Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pediatric patients with chickenpox (aged less than 15 years old).
    Exclusion criteria:
    • Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2011-28-02
    Actual study completion date
    2011-28-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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