Last updated: 01/15/2019 14:10:18

Special drug use investigation of XYZAL® Syrup 0.05%

GSK study ID
200559
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 of XYZAL® Syrup 0.05%
Trial description: This investigation will be conducted to collect and evaluate information regarding the safety and effectiveness of levocetirizine syrup in pediatric patients aged not less than 6 months to less than 7 years in the clinical practice.
The following item is set as the priority investigation item and the occurrence of the item will be collected.
•Adverse events (AEs) related to the nervous system, including convulsion (epilepsy, convulsion, febrile convulsion, tremor, irritability, somnolence, etc.)
XYZAL is a registered trademark of the UCB Group of Companies, used under license by the GSK Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of ADRs and infections in routine clinical practice

Timeframe: 12 weeks

Response rate

Timeframe: 12 weeks

Occurrence of AEs related to the nervous system, including convulsion (epilepsy, convulsion, febrile convulsion, tremor, irritability, somnolence, etc.)

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Levocetirizine
    • Enrollment:
    1000
    Primary completion date:
    2017-31-10
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Kanami Sugimoto ,Yoshifumi Inagaki , Mitsuhiro Yoshida , Hirohiko Murayama, Terufumi Hara , Wataru Sugiura. Safety and efficacy of levocetirizine hydrochloride syrup (Xyzal) in children (Special Drug Use Investigation Final Report). Jpn J Pediatr. 2018;71(12):2641-2651
    Medical condition
    Rhinitis, Allergic, Perennial and Seasonal
    Product
    levocetirizine
    Collaborators
    Not applicable
    Study date(s)
    August 2014 to October 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6Months - 6Years
    Accepts healthy volunteers
    None
    • Pediatric patients aged not less than 6 months to less than 7 years
    • Patients who were diagnosed as having allergic rhinitis, or skin diseases (urticaria, pruritus accompanying skin diseases (eczema/dermatitis, dermal pruritus))
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pediatric patients aged not less than 6 months to less than 7 years
    • Patients who were diagnosed as having allergic rhinitis, or skin diseases (urticaria, pruritus accompanying skin diseases (eczema/dermatitis, dermal pruritus))
    • Patients who are treated with levocetirizine for the first time
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2017-31-10
    Actual study completion date
    2017-31-10

    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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