Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)

Organon and Co204 enrolled

Overview

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.

This study is a cross-over study design.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

204

Conditions

Allergic Rhinitis

Interventions

Desloratadine (Clarinex)DRUG

Each subject received 5 mL of desloratadine syrup one time

Cetirizine (Zyrtec)DRUG

Each subject received 5 mL of cetirizine syrup

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: During the only study visit

Adverse Events

Time frame: During the only study visit

Data from ClinicalTrials.gov

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