Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Rhinitis
Interventions
DRUG

Levocetirizine

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

DRUG

Levocetirizine

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

Trial Locations (7)

260-0001

GSK Investigational Site, Chiba

136-0073

GSK Investigational Site, Tokyo

154-0002

GSK Investigational Site, Tokyo

154-0017

GSK Investigational Site, Tokyo

157-0066

GSK Investigational Site, Tokyo

158-0094

GSK Investigational Site, Tokyo

176-0012

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01563081 - Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics | Biotech Hunter | Biotech Hunter