Clinical trial NCT00780403: 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)
Official title: A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergies
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-10-27
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Primary outcomes:
measure: Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
timeFrame: Following the second dose (8-10 minutes after the first dose)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: