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Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

Primary Purpose

Urticaria

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
levocetirizine dihydrochloride
Sponsored by
UCB Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria focused on measuring Levocetirizine dihydrochloride, Xyzal tablets

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, 18 to 60 years old (inclusive
  • having chronic idiopathic urticaria
  • at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
  • moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization

Exclusion Criteria:

  • Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids
  • urticaria caused by physical factors or other known factors
  • cholinergic urticaria
  • had urticaria due to other systemic disorders
  • were on antihistamine drug currently

Sites / Locations

    Outcomes

    Primary Outcome Measures

    pruritus severity, assessed by the investigator over 2 weeks of treatment

    Secondary Outcome Measures

    Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety

    Full Information

    First Posted
    September 4, 2007
    Last Updated
    December 11, 2013
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00525382
    Brief Title
    Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
    Official Title
    A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    March 2004 (Actual)
    Study Completion Date
    March 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UCB Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urticaria
    Keywords
    Levocetirizine dihydrochloride, Xyzal tablets

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    134 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levocetirizine dihydrochloride
    Primary Outcome Measure Information:
    Title
    pruritus severity, assessed by the investigator over 2 weeks of treatment
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, 18 to 60 years old (inclusive having chronic idiopathic urticaria at least 6-weeks history of CIU, had at least 3 days of wheals presence/week moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization Exclusion Criteria: Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids urticaria caused by physical factors or other known factors cholinergic urticaria had urticaria due to other systemic disorders were on antihistamine drug currently
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Clinical Trial Call Center
    Organizational Affiliation
    UCB Pharma
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

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