Last updated: 11/04/2018 08:11:04

Evaluation Of Valaciclovir In Patients With Chickenpox

GSK study ID
HS2101951
See study documents
Clinicaltrials.gov ID
NCT00169416
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: Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients with Chickenpox - Open Uncontrolled Study.
Trial description: This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: valaciclovir HCl granules
    • Enrollment:
    43
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Varicella
    Product
    valaciclovir
    Collaborators
    Not applicable
    Study date(s)
    March 2005 to August 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    1 - 11 years
    Accepts healthy volunteers
    No
    • Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.
    • History of hypersensitivity reactions.
    • Impaired hepatic or renal function.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.
    Exclusion criteria:
    • History of hypersensitivity reactions.
    • Impaired hepatic or renal function.
    • Gastrointestinal dysfunction.
    • Serious underlying disease.
    • Weigh over 40kg.
    • Vaccinated for chickenpox.

    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
    Not applicable
    Actual study completion date
    2005-02-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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