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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00867191 |
The purpose of this study was to demonstrate the efficacy (% of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: Placebo Drug: Desloratadine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Centre, Double-Blind, Randomised Comparison Of The Effects Of Desloratadine (Aerius®) And Placebo In The Relief Of Nasal Symptom Scores In Subjects With Seasonal Allergic Rhinitis (Sar) To Cypress Pollen |
Enrollment: | 233 |
Study Start Date: | February 2002 |
Study Completion Date: | April 2003 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo, 1 tablet daily, per os
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Drug: Placebo
Placebo, 1 tablet daily, per os., 15 days
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2: Active Comparator
Desloratadine, one 5 mg tablet daily, per os
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Drug: Desloratadine
Desloratadine, one 5 mg tablet daily, per os, 15 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P02836 |
Study First Received: | March 20, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00867191 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Neurotransmitter Agents Otorhinolaryngologic Diseases Cholinergic Antagonists Rhinitis Cholinergic Agents Desloratadine Histamine Hypersensitivity |
Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists Respiratory Hypersensitivity |
Neurotransmitter Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Cholinergic Antagonists Physiological Effects of Drugs Histamine Agents Rhinitis Cholinergic Agents Desloratadine Pharmacologic Actions |
Nose Diseases Hypersensitivity Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |