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Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Desloratadine (Clarinex)
Cetirizine (Zyrtec)
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allergic Rhinitis

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must be:

  • Between 6 and 11 years of age in good general health
  • Premenarcheal if female

Exclusion Criteria:

Subjects who:

  • Have known allergies or sensitivities to either of the drug formulations
  • Have a medical condition that may interfere with the subject's ability to discriminate between tastes
  • Have used any antihistamines within 24 hours prior to dosing
  • Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
  • Were involved in another clinical or market research study within the past 30 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Desloratadine and Cetirizine Crossover

    Arm Description

    To compare the preference in taste between desloratadine and cetirizine.

    Outcomes

    Primary Outcome Measures

    Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).

    Secondary Outcome Measures

    Taste flavor preference between bubble-gum, banana-grape, or grape flavors
    Adverse Events

    Full Information

    First Posted
    November 19, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00794378
    Brief Title
    Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)
    Official Title
    A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.
    Detailed Description
    This study is a cross-over study design.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    202 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Desloratadine and Cetirizine Crossover
    Arm Type
    Experimental
    Arm Description
    To compare the preference in taste between desloratadine and cetirizine.
    Intervention Type
    Drug
    Intervention Name(s)
    Desloratadine (Clarinex)
    Other Intervention Name(s)
    SCH 034117, Clarinex
    Intervention Description
    Each subject received 5 mL of desloratadine syrup one time
    Intervention Type
    Drug
    Intervention Name(s)
    Cetirizine (Zyrtec)
    Other Intervention Name(s)
    Zyrtec
    Intervention Description
    Each subject received 5 mL of cetirizine syrup
    Primary Outcome Measure Information:
    Title
    Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).
    Time Frame
    During the only study visit
    Secondary Outcome Measure Information:
    Title
    Taste flavor preference between bubble-gum, banana-grape, or grape flavors
    Time Frame
    During the only study visit
    Title
    Adverse Events
    Time Frame
    During the only study visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must be: Between 6 and 11 years of age in good general health Premenarcheal if female Exclusion Criteria: Subjects who: Have known allergies or sensitivities to either of the drug formulations Have a medical condition that may interfere with the subject's ability to discriminate between tastes Have used any antihistamines within 24 hours prior to dosing Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs Were involved in another clinical or market research study within the past 30 days

    12. IPD Sharing Statement

    Learn more about this trial

    Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)

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