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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00795158
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urticaria Drug: desloratadine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Effects of Desloratadine Treatment on the Quality of Life of Patients With Chronic Urticaria
Study Start Date : November 2002
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: Arm 1 Drug: desloratadine
desloratadine 5 mg tablets; one tablet orally once a day for 28 days
Other Name: Clarinex; Aerius; SCH 34117; descarboethoxyloratadine

Primary Outcome Measures :
  1. Change from baseline to day 28 in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline and treatment day 28 ]

Secondary Outcome Measures :
  1. Change from Baseline in the DLQI score on treatment days 7, 14, 21 [ Time Frame: Baseline and treatment days 7, 14, 21 ]
  2. Change from Baseline in pruritus, the number of hives, sleep quality, and daily activity impairment on treatment days 7, 14, 21, and 28 [ Time Frame: Baseline and treatment days 7, 14, 21, and 28 ]
  3. Change from Baseline in the Overall Condition of chronic urticaria on treatment days 14 and 28 [ Time Frame: Baseline and treatment days 14 and 28 ]
  4. Percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief on treatment days 14 and 28 [ Time Frame: Treatment days 14 and 28 ]
  5. Evaluation of tolerability and safety by clinical laboratory tests [ Time Frame: Baseline and treatment day 28 ]
  6. Evaluation of tolerability and safety by adverse events [ Time Frame: Screening, Baseline, and treatment days 14 and 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications of Results:
Seidenari S, Cirillo A, Amoroso S, Flori ML, Amerio P, Ricciuti E, Vena GA, Berardesca E, Le Grazie C and the Italian Study Group on Desloratadine (DL) in Chronic Urticaria. Desloratadine 5 milligrams once daily improves quality of life in chronic idiopathic urticaria. G Ital Dermatol Venereol. 2006;141(3):207-214

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00795158    
Other Study ID Numbers: P02988
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents