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Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Primary Purpose

Cough

Status
Completed
Phase
Phase 2
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 Cough focused on measuring levocetirizine dihydrochloride Xyzal tablets

Eligibility Criteria

2 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants from 2 to 24 months both inclusive
  • suffering from recurrent cough associated with other allergic symptoms
  • hospitalized for respiratory or allergy related problems
  • laboratory results within normal ranges
  • height and weight between percentile 5 and 95

Exclusion Criteria:

  • having taken any of the disallowed medication
  • suffering form any disorder
  • history of sleep apnea
  • having concomitant chronic disease
  • known relevant renal, hepatic, cardiac or metabolism dysfunction
  • known alcohol or drug addiction, severe psychiatric disease for the parent/guardian

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The efficacy based on daily record cards recordings

    Secondary Outcome Measures

    Safety and pharmacokinetics at 90 days; skin reactivity

    Full Information

    First Posted
    August 24, 2007
    Last Updated
    December 11, 2013
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00520754
    Brief Title
    Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
    Official Title
    The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    March 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UCB Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levocetirizine dihydrochloride
    Primary Outcome Measure Information:
    Title
    The efficacy based on daily record cards recordings
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Safety and pharmacokinetics at 90 days; skin reactivity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infants from 2 to 24 months both inclusive suffering from recurrent cough associated with other allergic symptoms hospitalized for respiratory or allergy related problems laboratory results within normal ranges height and weight between percentile 5 and 95 Exclusion Criteria: having taken any of the disallowed medication suffering form any disorder history of sleep apnea having concomitant chronic disease known relevant renal, hepatic, cardiac or metabolism dysfunction known alcohol or drug addiction, severe psychiatric disease for the parent/guardian
    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

    Citations:
    PubMed Identifier
    15966463
    Citation
    Cranswick N, Turzikova J, Fuchs M, Hulhoven R. Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Int J Clin Pharmacol Ther. 2005 Apr;43(4):172-7. doi: 10.5414/cpp43172.
    Results Reference
    result

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    Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

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