NCT00779116

Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications (Study P04574)(COMPLETED)

A Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

Summary

This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.

Conditions

• Allergies

Interventions

Type	Name	Description
DRUG	Desloratadine	SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
DRUG	Zyrtec® (cetirizine)	Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2008-10-24
• Last updated: 2022-02-09
• Results posted: 2010-07-05