This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
desloratadine syrup: 1.25 mg (2.5 mL) for subjects \>=2 to \<6 years, 2.5 mg (5 mL) for subjects \>=6 to \<12 years, orally once daily in the morning for 36 days.
placebo syrup: 2.5 mL for subjects \>=2 to \<6 years, 5 mL for subjects \>=6 to \<12 years, orally once daily in the morning for 36 days.
Safety and Tolerance
Time frame: Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).
Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36.
Time frame: Days 15 and Days 36
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