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)

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• 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.

• Subject was to be 6-11 years of age, of either sex and of any race.

• If female, subject was to be premenarcheal.

• Subject was to be willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.

• Subject was to be free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.

• Subject was to have understood and been 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 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.