Last updated: 01/15/2019 14:10:18
Special drug use investigation of XYZAL® Syrup 0.05%
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2017-31-10
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)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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