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Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 4
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 Rhinitis, Allergic, Seasonal focused on measuring Levocetirizine dihydrochloride, Xyzal tablets

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults 18 to 55 years both inclusive
  • suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
  • positive RAST and/or positive skin prick test
  • comply with study restrictions

Exclusion Criteria:

  • known alcohol or drug addiction or abuse
  • known allergy/intolerance to lactose, cellulose, cornstarch
  • presence of nasal anatomical deformities leading to > 50% obstruction
  • ENT infection within 30 days of the study
  • use of disallowed medication
  • ongoing desensitization
  • known cardiac, renal or hepatic dysfunction
  • presenting allergic bronchial asthma
  • use of cimetidine
  • intending to donate blood during the trial

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

    Secondary Outcome Measures

    The change from baseline of the mean MSC score over time interval 3
    the change from baseline of the mean MSC score over time intervals 1 and 4.

    Full Information

    First Posted
    October 10, 2007
    Last Updated
    December 11, 2013
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00542607
    Brief Title
    Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
    Official Title
    Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    December 2002 (Actual)
    Study Completion Date
    December 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UCB Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levocetirizine dihydrochloride
    Primary Outcome Measure Information:
    Title
    Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
    Secondary Outcome Measure Information:
    Title
    The change from baseline of the mean MSC score over time interval 3
    Title
    the change from baseline of the mean MSC score over time intervals 1 and 4.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adults 18 to 55 years both inclusive suffering at least 2 years of seasonal allergic rhinitis due to grass pollen positive RAST and/or positive skin prick test comply with study restrictions Exclusion Criteria: known alcohol or drug addiction or abuse known allergy/intolerance to lactose, cellulose, cornstarch presence of nasal anatomical deformities leading to > 50% obstruction ENT infection within 30 days of the study use of disallowed medication ongoing desensitization known cardiac, renal or hepatic dysfunction presenting allergic bronchial asthma use of cimetidine intending to donate blood during the trial
    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

    Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

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