Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
Condition: Rhinitis
MeSH terms: Rhinitis
Intervention: Levocetirizine; Levocetirizine
Intervention description: Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered once daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning to infants aged between 6 months and 1 year old; Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered twice daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning and evening before sleep to infants aged between 1 year and 2 years old
Intervention MeSH terms: Cetirizine; Levocetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Months
Healthy volunteers: No
Keywords: Allergic rhinitis; Pediatric; Pruritus; Levocetirizine

Summary:

      To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients
      aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin
      diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients

          -  Either boys or girls are acceptable.

          -  Pediatric patients ranging from 6 months to 2 years in age at the time of initiation
             of the treatment in clinical trial

          -  Pediatric patients who have at least one of the symptoms associated with allergic
             rhinitis including rhinorrhea, nasal congestion and sneezing, and require at least
             2-week treatment with antihistamine drugs, or those who suffer from pruritus
             associated with the following diseases and require at least 2-week treatment with
             antihistamine drugs (- Chronic urticaria, - Eczema/dermatitis group: atopic dermatitis
             etc. [A diagnosis of atopic dermatitis is made in accordance with the
             "Definition/Diagnostic Criteria of Atopic Dermatitis, - Prurigo group: acute prurigo
             (strophulus, urticaria-like lichen, etc.), subacute prurigo, chronic prurigo (nodular
             prurigo etc.), - Pruritus cutaneous: systemic pruritus cutaneous, local pruritus
             cutaneous)

          -  Pediatric patients with QTc interval below 450 msec. QTc interval shall be below 480
             msec in the pediatric patients with bundle branch block at screening (A judgment shall
             be made according to the QTc interval based on ECG result corresponding to one heart
             beat or the QTc interval based on the mean of ECG results corresponding to 3 heart
             beats.)

          -  AST<2×upper limit of normal, ALT<2×upper limit of normal, alkaline
             phosphatase≤1.5×upper limit of normal, bilirubin≤1.5×upper limit of normal at
             screening (The serum bilirubin shall be fractioned and the direct bilirubin shall be
             below 35%. In this case, the free bilirubin level exceeding 1.5 times the upper limit
             of normal is acceptable.)

          -  Pediatric patients whose parents (persons with parental authority or guardians) shall
             submit written informed consent

          -  Pediatric patients whose parents (persons with parental authority or guardians) shall
             fill the medication diaries

        Exclusion Criteria:

          -  Pediatric patients whose body weight is above or below the infantile growth curves
             shown in the infant body growth investigation report in 2011 [MHLW, 2011]

          -  Pediatric patients breast-fed by mothers who take any antihistamine drugs during the
             study period

          -  Pediatric patients who received systemic adrenocorticosteroids within 28 days before
             Visit 2

          -  Pediatric patients who are currently treated or planned to have immunotherapy
             initiated during the study period

          -  Pediatric patients who had abnormal laboratory results that were unrelated to allergic
             disorders [These patients can be enrolled if the investigator (or sub-investigator)
             judges that their enrolment poses no clinical problem.]

          -  Pediatric patients who require application of adrenocorticosteroids for external use
             that are classified as "strongest," "very strong" or "strong"

          -  Pediatric patients who suffer from asthma as a complication and require treatment with
             adrenocorticosteroids (including adrenocorticosteroid combinations)

          -  Pediatric patients with the history of convulsion, febrile convulsion or sleep apnea

          -  Pediatric patients whose brothers or sisters have history of sleep apnea or sudden
             infant death syndrome

          -  Pediatric patients with history of allergy or hypersensitivity to the ingredients of
             levocetirizine hydrochloride preparation or piperazine derivatives such as
             hydroxyzine, cetirizine, cyclizine

          -  Pediatric patients with history of drug hypersensitivity

          -  Pediatric patients who are considered inappropriate as the subjects of this clinical
             trial because of liver diseases, renal diseases, heart diseases or other complications
             that pose clinical problem

          -  Pediatric patients whose parents are minors

          -  Infants who belong to children's institutions

          -  Pediatric patients who participated in other clinical trials for 6 months before
             enrolment or those who intend to participate in other clinical trials during the
             clinical trial period.

          -  Person meeting any of the following criteria and his/her family (- An employee of
             GlaxoSmithKline K.K., - Investigator or sub-investigator, - An employee of Site
             Management Organization (SMO) related with the clinical study)

          -  Other pediatric patients who are judged as inappropriate for participating in this
             clinical trial by the investigator (or sub-investigator)