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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00780403 |
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
Condition | Intervention | Phase |
---|---|---|
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) Abd Zyrtec ® 5.0 mg Chewable Tablet Medications |
Enrollment: | 220 |
Study Start Date: | August 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Desloratadine
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Drug: Desloratadine
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
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2: Active Comparator
Zyrtec
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Drug: Zyrtec® (cetirizine)
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, 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:
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.
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04573 |
Study First Received: | October 23, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00780403 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Hypersensitivity Cholinergic Antagonists Histamine Antagonists Histamine phosphate Histamine H1 Antagonists |
Anti-Allergic Agents Cholinergic Agents Cetirizine Desloratadine Histamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Histamine Agents Anti-Allergic Agents Cholinergic Agents |
Cetirizine Desloratadine Pharmacologic Actions Histamine Antagonists Therapeutic Uses Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |