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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00795158
First received: November 20, 2008
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Urticaria
Drug: desloratadine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline to day 28 in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline and treatment day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the DLQI score on treatment days 7, 14, 21 [ Time Frame: Baseline and treatment days 7, 14, 21 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of tolerability and safety by clinical laboratory tests [ Time Frame: Baseline and treatment day 28 ] [ Designated as safety issue: Yes ]
  • Evaluation of tolerability and safety by adverse events [ Time Frame: Screening, Baseline, and treatment days 14 and 28 ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: November 2002
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00795158     History of Changes
Other Study ID Numbers: P02988
Study First Received: November 20, 2008
Last Updated: May 1, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Urticaria
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular
Desloratadine
Cholinergic Agents
Cholinergic Antagonists
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014