Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Rhinitis

Clinical Trial Details

NCT number	NCT01563081
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 3
Start date	April 2012
Completion date	August 2012

View Details

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