Overview

Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Cetirizine
Desloratadine
Loratadine
Criteria
Inclusion Criteria:

- Subject and the parent/guardian of the subject, was to have demonstrated their
willingness to participate in the study and comply with its procedures by signing a
written Informed Consent

- 6-11 years old, either sex, either race

- If female, subject to be premenarcheal

- Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior
to enrollment.

- Free of any clinically significant disease that would interfere with study
evaluations, including allergic rhinitis and respiratory infections.

- Able to adhere to the dosing and visit schedules

Exclusion Criteria:

- If female, subject who was pregnant, intended to become pregnant during the study or
nursing.

- Subject had used any investigational product within 30 days prior to enrollment.

- Subject had any of the following clinical conditions: history of any significant
medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart
disease, liver disease, kidney disease, breathing problems, cough with excessive
phlegm, or persistent or chronic cough.

- Subject had a current medical condition that, in the opinion of the Investigator or
designee, may interfere with the ability to discriminate taste (e.g., common cold,
sinus infection, bronchial infection, allergic rhinitis, etc.).

- Subject was participating in any other clinical study(ies).

- Subject was part of the staff or a family member of the staff personnel directly
involved with this study.

- Subject was allergic to or has sensitivity to the study drug or its excipients.

- Subject had a history of allergic reaction to prescription and/or over the counter
(OTC) medications and/or food products.

- Subject had used any antihistamines within 24 hours prior to tasting as outlined in
Section 9.4.7.

- Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.