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)

Organon

Status and phase: Completed; Phase 4

Conditions: Allergies

Treatments: Drug: Desloratadine; Drug: Zyrtec® (cetirizine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00779116

P04574

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

RediTab/Zyrtec

Active Comparator group

Description:

Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference.

Treatment:

Drug: Desloratadine

Drug: Zyrtec® (cetirizine)

Zyrtec/RediTab

Active Comparator group

Description:

Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.

Treatment:

Drug: Desloratadine

Drug: Zyrtec® (cetirizine)