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)
Condition: Allergies
Intervention: Desloratadine; Zyrtec® (cetirizine)
Intervention description: desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day; Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, 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: 220.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

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

          -  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.