Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rhinitis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 623 years
- Gender
- Both males and females
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 ...
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).
Tracking Information
- NCT #
- NCT01563081
- Collaborators
- Not Provided
- Investigators
- Study Director: GSK Clinical Trials GlaxoSmithKline
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