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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00405964 |
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis.
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Drug: 5-mg Desloratadine Drug: Placebo tablet |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Persistent Allergic Rhinitis (PER) |
Estimated Enrollment: | 800 |
Study Start Date: | August 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
5-mg Desloratadine tablet: Experimental |
Drug: 5-mg Desloratadine
5-mg Desloratadine tablet, once daily for 12 weeks
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Placebo tablet: Placebo Comparator |
Drug: Placebo tablet
Placebo tablet, once daily for 12 weeks
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology ) |
Study ID Numbers: | P04684 |
Study First Received: | November 30, 2006 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00405964 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Histamine phosphate |
Rhinitis Desloratadine Histamine |
Neurotransmitter Agents Histamine Antagonists Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Histamine Agents |
Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Cholinergic Agents Pharmacologic Actions Nose Diseases |