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A Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications
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.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 217 |
| Start date | 2005-09 |
| Completion | 2005-10 |
Conditions
- Allergies
Interventions
- Desloratadine
- Zyrtec® (cetirizine)
Primary outcomes
- Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. — Following the second dose (8-10 minutes after the first dose)
A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.