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)
Condition: Allergies
Intervention: Desloratadine; Zyrtec® (cetirizine)
Intervention description: SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day; Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
Intervention MeSH terms: Cetirizine; Desloratadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.