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| Sponsor: | 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 (PER)
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: 5-mg Desloratadine Drug: Placebo tablet |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
| Enrollment: | 716 |
| Study Start Date: | September 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 5-mg Desloratadine tablet |
Drug: 5-mg Desloratadine
5-mg Desloratadine tablet, once daily for 12 weeks
Other Name: SCH 34117, Aerius
|
| Placebo Comparator: Placebo tablet |
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: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00405964 History of Changes |
| Other Study ID Numbers: | P04684 |
| Study First Received: | November 30, 2006 |
| Results First Received: | March 25, 2009 |
| Last Updated: | October 22, 2010 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Desloratadine Loratadine Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Antipruritics Dermatologic Agents Therapeutic Uses Anti-Allergic Agents |