Last updated: 11/07/2018 08:33:50

Drug Use Investigation for XYZAL®

GSK study ID
115066
See study documents
Clinicaltrials.gov ID
NCT01445262
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: Drug Use Investigation for XYZAL
Trial description: This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of adverse events in Japanese subjects treated with levocetirizine tablets

Timeframe: 4 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Levocetirizine
    • Enrollment:
    10728
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Tamami Kaneko, Ryoko Tanaka, Terufumi Hara, Pascal Yoshida.Safety and efficacy of levocetirizine hydrochloride (Xyzal® Tablets 5mg) in patients with allergic rhinitis and skin diseases - Drug Use Investigation Final Report (Study No : 115066) -.J Clin Therapeut Med.2014;30(10):885-903
    Medical condition
    Rhinitis, Allergic, Perennial and Seasonal
    Product
    levocetirizine
    Collaborators
    Not applicable
    Study date(s)
    February 2011 to December 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Must be the first time for taking levocetirizine tablet
    • As this is PMS study, there are no exclusion criteria.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Must be the first time for taking levocetirizine tablet
    Exclusion criteria:
    • As this is PMS study, there are no exclusion criteria.

    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
    2013-27-12

    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
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