Last updated: 02/04/2020 18:40:05

Special Drug Use Investigation for XYZAL (Long-term)

GSK study ID
115068
See study documents
Clinicaltrials.gov ID
Not applicable
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 XYZAL (Long-term)
Trial description: This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data for long-term use among patients with allergic rhinitis or skin disease who are treated with levocetirizine tablets for the first time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Changes in clinical symptoms

Timeframe: 24 weeks

Occurrence of adverse drug reactions under clinical practice

Timeframe: 24 weeks

Changes in quality of life's scores

Timeframe: 24 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Levocetirizine tablets
    • Enrollment:
    511
    Primary completion date:
    2016-08-02
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Kanami Sugimoto; Yukiko Ashihara; Kyoko Murakami; Terufumi Hara. Long-Term Safety and efficacy of levocetirizine hydrochloride (Xyzal? Tablets 5 mg) in patients with allergic rhinitis and skin diseases - Special Drug Use Investigation Final Report. J Clin Therapeut Med. 2016;32(11):905-922.
    Medical condition
    Rhinitis, Allergic, Perennial and Seasonal
    Product
    levocetirizine
    Collaborators
    Not applicable
    Study date(s)
    September 2012 to February 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Adult patients with allergic rhinitis, urticaria, eczema/dermatitis,prurigo or pruritus cutaneous
    • Pediatric patients with allergic rhinitis, urticaria or itching associated with skin diseases (eczema/dermatitis, pruritus cutaneous)
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adult patients with allergic rhinitis, urticaria, eczema/dermatitis,prurigo or pruritus cutaneous
    • Pediatric patients with allergic rhinitis, urticaria or itching associated with skin diseases (eczema/dermatitis, pruritus cutaneous)
    • Patients who are treated with levocetirizine for the first time
    • Patients who are expected for long-term use (24 weeks)
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2016-08-02
    Actual study completion date
    2016-08-02

    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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