A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)

Inclusion Criteria:

• Have demonstrated their willingness to participate in the study and comply with itsprocedures by signing a written informed consent. For pediatric patients, the parentor legal guardian was to have signed a written informed consent.

• Be between 12 and 70 years of age, of either sex and any race.

• Have had signs and symptoms of CIU for at least 6 weeks prior to the ScreeningVisit.

• Have been experiencing a current flare of their CIU of at least 3 weeks prior to theBaseline Visit. Hives were to have been present for at least 3 days per week duringthe current flare prior to the Baseline Visit.

• Have an overall condition of CIU that was at least of "moderate" severity (minimumscore of 2) at both Screening and Baseline Visits.

• Have at least a moderately severe pruritus score (minimum score of 2) and hives (minimum score of 1) present at Screening.

• Have, at Baseline, a total pruritus score of 14 or greater for the sum of AM and PM (reflective) diary scores for the 3 days prior to Baseline and the AM diary score onDay 1.

• Understand and be able to adhere to the dosing and visit schedules, and agree toassess and record their symptom severity scores, medication times,concomitantmedications, and adverse events accurately and consistently in a daily diary.

• Be in general good health and free of any clinically significant disease (other thanCIU) that would have interfered with study evaluations.

• If female and of childbearing potential, have had a negative urine (hCG) pregnancytest at the time of Baseline (Visit 2).

• Female subjects of childbearing potential were to be counseled in the appropriateuse of birth control while in the study. They were to be using a medically acceptedmethod of birth control, for example: double barrier method, oral contraceptive,Depo-Provera®, or Norplant®, prior to Baseline and during the study. Women who werenot sexually active were to agree and consent to use one of the above-mentionedmethods should they become sexually active while participating in the study. If thesubject had had a tubal ligation or was using an intra-uterine device, or if thehusband/partner had had a vasectomy, another method was to be used.

Exclusion Criteria:

• Had asthma requiring chronic use of inhaled or systemic corticosteroids.

• Had been unresponsive to antihistamine treatment in the past.

• Had a history of allergies to more than two classes of medication or who wereallergic to or unable to tolerate antihistamines.

• Had used any investigational drug in the last 30 days prior to Baseline.

• Had food or drug allergies manifested as skin reactions. Subjects with urticariathat was primarily due to physical urticaria or other known etiology.

• If female, were pregnant or nursing.

• Had a history of hypersensitivity to the study drug or its excipients.

• Were family members of the investigational study staff involved with this study.

• Had previously been randomized into the study.

• Had current evidence of clinically significant hematopoietic, cardi distribution,metabolism, or excretion of the study medication or with the subject's ability toreliably complete the diary card.

• Were morbidly obese (BMI >= 35, as described in Appendix 6 of the protocol)

• Had a compromised ability to provide informed consent.

• Had a history of non-compliance with medications or treatment protocols.