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

Allergic Rhinitis Clinical Trial

Official title:

A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794794
• Other study ID #: P03826
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: November 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a cross-over study design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Desloratadine (Clarinex)
Each subject received 5 mL of desloratadine syrup one time
• Cetirizine (Zyrtec)
Each subject received 5 mL of cetirizine syrup

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).		During the only study visit
Secondary	Taste flavor preference between bubble-gum, banana-grape, or grape flavors		During the only study visit
Secondary	Adverse Events		During the only study visit