Clarinex

[Desloratadine]

Chronic Idiopathic Urticaria:

The efficacy and safety of CLARINEX Tablets 5 mg once daily was studied in 416 chronic idiopathic urticaria patients 12 to 84 years of age, of whom 211 received CLARINEX. In two double-blind, placebo-controlled, randomized clinical trials of six weeks' duration, at the pre-specified one-week primary time point evaluation, CLARINEX Tablets significantly reduced the severity of pruritus when compared to placebo (Table 4). Secondary endpoints were also evaluated and during the first week of therapy CLARINEX Tablets 5 mg reduced the secondary endpoints, "Number of Hives" and the "Size of the Largest Hive," when compared to placebo.

Table 4

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PRURITUS SYMPTOM SCORE (TSS) Changes in the First Week of a Clinical Trial in Patients with Chronic Idiopathic Urticaria

Treatment Mean Change from Placebo Group Baseline Baseline* Comparison
(n) (sem) (sem) (P-value)
CLARINEX 5.0 mg (115) 2.19 (0.04) -1.05 (0.07) P< 0.01

Placebo (110) 2.21 (0.04) -0.52 (0.07)
Pruritus scored 0 to 3 where 0= no symptom to 3= maximal symptom. *Mean reduction in pruritus averaged over the first week of treatment.

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