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

Phase 3
Completed
Conditions
Allergic Rhinitis
Interventions
Registration Number
NCT00794378
Lead Sponsor
Organon and Co
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
202
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Desloratadine and Cetirizine CrossoverCetirizine (Zyrtec)To compare the preference in taste between desloratadine and cetirizine.
Desloratadine and Cetirizine CrossoverDesloratadine (Clarinex)To compare the preference in taste between desloratadine and cetirizine.
Primary Outcome Measures
NameTimeMethod
Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).During the only study visit
Secondary Outcome Measures
NameTimeMethod
Taste flavor preference between bubble-gum, banana-grape, or grape flavorsDuring the only study visit
Adverse EventsDuring the only study visit
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