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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00779636 |
This was a placebo controlled study designed to evaluate the effectiveness of desloratadine in relieving symptoms of allergic airway disease during the pollen season. Patients received desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping study drug).
Condition | Intervention | Phase |
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Allergic Airway Disease |
Drug: Desloratadine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Safety of Desloratadine 10 mg Daily vs. Placebo in Subjects With Allergic Airway Disease During the Pollen Season |
Enrollment: | 506 |
Study Start Date: | July 2003 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Desloratadine 10 mg: Experimental |
Drug: Desloratadine
Desloratadine 10 mg daily x 28 days
|
Placebo: Placebo Comparator |
Drug: Placebo
Placebo daily x 28 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03284 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779636 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Histamine Antagonists Cholinergic Antagonists Loratadine Antipruritics Histamine phosphate |
Histamine H1 Antagonists Anti-Allergic Agents Cholinergic Agents Desloratadine Histamine |
Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Anti-Allergic Agents Cholinergic Agents Desloratadine |
Pharmacologic Actions Loratadine Histamine Antagonists Therapeutic Uses Histamine H1 Antagonists Antipruritics Histamine H1 Antagonists, Non-Sedating Dermatologic Agents |