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Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis

Primary Purpose

Rhinitis, Allergic, Perennial

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

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Cetirizine, Zyrtec

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
  • severity of nasal symptoms was moderate to severe during the observation period;
  • criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.

Exclusion Criteria:

  • history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
  • history of drug hypersensitivity;
  • history of convulsive disorder;
  • vasomotor rhinitis or eosinophilic rhinitis;
  • asthma requiring treatment with adrenocortical hormones;
  • concomitant diseases which could impede the efficacy evaluation of the study drug;
  • subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage;
  • pollen allergy;
  • malignant neoplasm.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments

    Secondary Outcome Measures

    Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating

    Full Information

    First Posted
    March 14, 2008
    Last Updated
    September 3, 2009
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00639587
    Brief Title
    Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
    Official Title
    A Double-blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (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
    Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis, Allergic, Perennial
    Keywords
    Cetirizine, Zyrtec

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    149 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ketotifen
    Intervention Description
    Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Cetirizine
    Intervention Description
    Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
    Primary Outcome Measure Information:
    Title
    Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
    Time Frame
    TSS: 2 weeks - Safety: 3 weeks
    Secondary Outcome Measure Information:
    Title
    Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
    Time Frame
    T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion; severity of nasal symptoms was moderate to severe during the observation period; criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge. Exclusion Criteria: history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine; history of drug hypersensitivity; history of convulsive disorder; vasomotor rhinitis or eosinophilic rhinitis; asthma requiring treatment with adrenocortical hormones; concomitant diseases which could impede the efficacy evaluation of the study drug; subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage; pollen allergy; malignant neoplasm.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Clinical Trial Call Center
    Organizational Affiliation
    +1-877-822-9493 (UCB)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis

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