This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
174
desloratadine, 5mg oral tablets, once daily for 28 days
placebo, once daily for 28 days
cetirizine, 10 mg capsules once daily for 28 days
Compare the efficacy of the study treatments with respect to the change from Baseline in the average AM/PM 12-hour reflective pruritus severity score (diary recordings) after the first 7 days of treatment.
Time frame: 7 days
Joint physician-patient evaluations ("now") at treatment days 14 and 28 (Visit 3 and 4) of overall condition of the CIU and overall global therapeutic response
Time frame: Days 14 and 28 (visits 3 and 4)
Average AM/PM "reflective" diary scores over for: severity of pruritus; number of hives; size of largest hives; total symptom score; subject-evaluated CIU interference with sleep (AM) and interference with daily activities (PM).
Time frame: Treatment days 1-7, 8-14, 15-21 and 22-28
Adverse event reports and vital sign evaluations
Time frame: Upon occurance
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