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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00779116 |
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.
Condition | Intervention | Phase |
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Allergies |
Drug: Desloratadine Drug: Zyrtec® (cetirizine) |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
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 |
Enrollment: | 217 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
desloratadine reditabs
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Drug: Desloratadine
SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
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2: Active Comparator
Zyrtec® (cetirizine) tablets
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Drug: Zyrtec® (cetirizine)
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
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Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04574 |
Study First Received: | October 23, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00779116 |
Health Authority: | United States: Food and Drug Administration |
Hypersensitivity Histamine phosphate Cetirizine Desloratadine Histamine |
Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Histamine Antagonists Therapeutic Uses Physiological Effects of Drugs |
Histamine Agents Histamine H1 Antagonists Anti-Allergic Agents Cholinergic Agents Histamine H1 Antagonists, Non-Sedating Pharmacologic Actions |