How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)
How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)
The purpose of this study was to determine the effect of desloratadine treatment on quality
 of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients
 who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week,
 patients filled out a questionnaire to tell how their hives affected their lives. This
 questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a
 diary every day to tell how much itching they had, how many hives they had, and how their
 hives had affected their sleep or daily activities. The patients and doctors rated the
 patients' overall condition and how much relief patients got from treatment.
Inclusion Criteria:

 -  Subjects must demonstrate their willingness to participate into the study and comply
 with its procedures by signing a written informed consent.

 -  Subjects must be >=18 years of age, of either sex and any race.

 -  Women of childbearing potential (includes women who are less than 1 year
 postmenopausal) must be using an acceptable method of birth control since at least one
 month prior to visit 1 (e.g., hormonal contraceptive, medically prescribed IUD, condom
 in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or
 tubal ligation). Women of childbearing potential should be counseled in the
 appropriate use of birth control while in this study.

 -  Subjects must be in general good health as confirmed by medical history and, physical
 examination; i.e., they must be free of any clinically significant disease (other than
 chronic urticaria [CU]) that would interfere with study evaluations.

 -  Subjects must understand and be able to adhere to the dosing and visit schedules, and
 agree to complete the questionnaires and to record accurately and consistently in a
 daily diary symptom severity scores, medication times, concomitant medications, and
 adverse events.

 -  Subjects must have a history of CU defined as at least 6 weeks of pruritus and hives
 with hives lasting less than 24 hours and occurring at least 2 days per week.

 -  Subjects must be experiencing a current CU flare with hives present at least 2 days in
 the week prior to the consent visit/visit 1.

 -  Subjects must have a pruritus score >=2 and a hive score >=1 at consent visit/Visit 1
 or during the 12 hours before the consent visit/Visit 1

 -  Subjects must score the Overall Condition of CU >=2 at both consent visit/Visit 1 and
 Visit 2 (Baseline).

 -  Subjects must have a total pruritus score of >=11 for the sum of morning (AM) and
 evening (PM) (reflective) diary scores for the 3 days prior to Visit 2 (Baseline) plus
 the morning score on the day of Visit 2

 -  Women of childbearing potential must have a negative urine pregnancy test at Visit 2
 (Baseline).

 Exclusion Criteria:

 -  Women who are pregnant or nursing.

 -  Subjects who have not observed the designated washout periods for any of the
 prohibited medications

 -  Subjects with asthma

 -  Subjects with drug or food allergies that manifest as skin reactions during 1 year
 prior to consent visit / visit 1

 -  Subjects with atopic dermatitis

 -  Subjects with urticaria that is primarily due to physical urticaria or other known
 etiology (on the basis of clinical history and physical examination).

 -  Subjects with CU unresponsive to antihistamines.

 -  Subjects under regular treatment with NSAIDs.

 -  Subjects who have been hospitalized because of worsening in their CU within 3 months
 prior to Visit 1 (Screening).

 -  Subjects with a history of hypersensitivity to Desloratadine or any of its excipients.

 -  Subjects previously enrolled into this study (i.e. who have been assigned to
 treatment).

 -  Subjects who are staff personnel directly involved with the administration of this
 study.

 -  Subjects who have any clinically significant metabolic, cardiovascular, immunologic,
 neurologic, hematologic, neoplastic, gastrointestinal, cerebrovascular, or respiratory
 disease, or any other disorder which, in the judgment of the Investigator, may
 interfere with the study evaluations or affect subject safety.

 -  Subjects with a history of psychosis, antagonistic personality, poor motivation,
 hypochondriasis, or any other emotional or intellectual problems that are likely to
 limit the validity of consent to participate in the study.

 -  Subjects with a history of noncompliance with medications or treatment protocols.

 -  Subject treated with any investigational drug in the last 30 days prior to baseline