Conditions: Rhinitis
Keywords: Allergic rhinitis Pediatric Pruritus Levocetirizine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief 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.

Detailed description:
This is a multi-center, open-labelled study to confirm the safety as main objective, and consisting of minimum 1-week screening period and 2-week treatment period. The subjects who meet the inclusion criteria are to be placed on one of the following two regimens according to their ages at the start of treatment period: once daily administration of levocetirizine at a dose of 1.25 mg (in the morning) to infants aged between 6 months and 1 year old (younger age group), and twice daily administration of levocetirizine at a dose of 1.25 mg (in the morning, in the evening before sleep) to infants aged between 1 year and 2 years old (older age group).

Arms:
arm 1: Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution

Interventions: intervention 1: Levocetirizine intervention 2: Levocetirizine
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: