The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
173
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
The RR interval refers to the respective time interval in the Electrocardiogram (ECG).
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
The PR interval refers to the respective time interval in the Electrocardiogram (ECG).
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time frame: Baseline, 14 days
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time frame: 7 days
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Little Rock, Arkansas, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Crescent City, California, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Mission Viejo, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Wildomar, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Pueblo, Colorado, United States
...and 18 more locations
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time frame: 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Time frame: Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Time frame: Baseline, 14 days