Clinical trial NCT00779116: 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)
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: 2008-10-24
Enrollment: 217
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: 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.

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:
citation: Tassinari P, Suarez NR, Centeno J, Velasquez JV, Aguirre-Mariscal H, Gonzalezdiaz SN, Jerves AF; LA Desloratadine Study Group. Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years. World Allergy Organ J. 2009 Apr;2(4):42-8. doi: 10.1097/WOX.0b013e31819cdfdb.