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| Sponsored by: |
Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00405964 |
Purpose
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
|
| Placebo tablet: Placebo Comparator |
Drug: Placebo tablet
Placebo tablet, once daily for 12 weeks
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Histamine Antagonists Cholinergic Antagonists Respiratory Tract Infections Respiratory Tract Diseases |
Histamine phosphate Histamine H1 Antagonists Rhinitis Cholinergic Agents Desloratadine Histamine |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Rhinitis Cholinergic Agents |
Desloratadine Nose Diseases Pharmacologic Actions Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |