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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
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
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 220 |
| Start date | 2005-08 |
| 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.