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[Desloratadine]

Table 2
TOTAL SYMPTOM SCORE (TSS) Changes in a 2 Week Clinical Trial in Patients with Seasonal Allergic Rhinitis

Treatment Mean Change from Placebo Group Baseline* Baseline** Comparison
(n) (sem) (sem) (P-value)
CLARINEX 5.0 mg (171) 14.2 (0.3) -4.3 (0.3) P< 0.01

Placebo (173) 13.7 (0.3) -2.5 (0.3)
*At baseline, a total nasal symptom score (sum of 4 individual symptoms) of at least 6 and a total non-nasal symptom score (sum of 4 individual symptoms) of at least 5 (each symptom scored 0 to 3 where 0= no symptom and 3= severe symptoms) was required for trial eligibility. TSS ranges from 0= no symptoms to 24= maximal symptoms.

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** Mean reduction in TSS averaged over the 2-week treatment period.
There were no significant differences in the effectiveness of CLARINEX Tablets 5 mg across subgroups of patients defined by gender, age, or race.

Perennial Allergic Rhinitis:

The clinical efficacy and safety of CLARINEX Tablets 5 mg were evaluated in over 1,300 patients 12 to 80 years of age with perennial allergic rhinitis. A total of 685 patients received 5 mg/ day of CLARINEX in 2 double-blind, randomized, placebo-controlled clinical trials of 4 weeks' duration conducted in the United States and internationally. In one of these studies CLARINEX Tablets 5 mg once daily was shown to significantly reduce symptoms of perennial allergic rhinitis (Table 3).

PRODUCT INFORMATION
CLARINEX ® (desloratadine)

TABLETS, REDITABS ® TABLETS

Table 3
TOTAL SYMPTOM SCORE (TSS) Changes in a 4 Week Clinical Trial in Patients with Perennial Allergic Rhinitis

Treatment Mean Change from Placebo Group Baseline* Baseline** Comparison
(n) (sem) (sem) (P-value)
CLARINEX 5.0 mg (337) 12.37 (0.18) -4.06 (0.21) P= 0.01

Placebo (337) 12.30 (0.18) -3.27 (0.21)
*At baseline, average of total symptom score (sum of 5 individual nasal symptoms and 3 non-nasal symptoms, each symptom scored 0 to 3 where 0= no symptom and 3= severe symptoms) of at least 10 was required for trial eligibility. TSS ranges from 0= no symptoms to 24= maximal symptoms. ** Mean reduction in TSS averaged over the 4-week treatment period.

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