Status:
COMPLETED
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)
Lead Sponsor:
Organon and Co
Conditions:
Allergies
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
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 preferen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00779116
Start Date
September 1 2005
End Date
October 1 2005
Last Update
February 9 2022
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