Last updated: 11/07/2018 04:42:30

Special Drug Use Investigation for VALTREX (Valaciclovir) (suppression prophylaxis)

GSK study ID
112319
See study documents
Clinicaltrials.gov ID
NCT01390805
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) (suppression prophylaxis)
Trial description: The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Valaciclovir Hydrochloride.
    • Enrollment:
    462
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Takashi Kawana, Mariko Honda, Hideyuki Okano, Yuko Suzuki, Shogo Inoshiri, Shoichi Onodera. Valaciclovir Hydrochloride (Valtrex® Tablets 500 / Valtrex® Granules 50%) for the Suppression of Recurrent Genital Herpes: A Special Drug Use Investigation in Japan. [Jpn J Sex Trans Dis]. 2012;23(1):108-118.
    Medical condition
    Genital Herpes
    Product
    valaciclovir
    Collaborators
    Not applicable
    Study date(s)
    November 2006 to March 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Subjects who started suppressive therapy for recurrent genital herpes for the first time
    • Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who started suppressive therapy for recurrent genital herpes for the first time
    Exclusion criteria:
    • Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir

    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
    2011-31-03

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website