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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00751218 |
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
Condition | Intervention | Phase |
---|---|---|
Urticaria |
Drug: desloratadine Drug: placebo Drug: cetirizine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (CIU) |
Enrollment: | 174 |
Study Start Date: | May 2004 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator
desloratadine
|
Drug: desloratadine
desloratadine, 5mg oral tablets, once daily for 28 days
|
Arm 2: Placebo Comparator
Placebo
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Drug: placebo
placebo, once daily for 28 days
|
Arm 3: Active Comparator
cetirizine
|
Drug: cetirizine
cetirizine, 10 mg capsules once daily for 28 days
|
Ages Eligible for Study: | 12 Years to 70 Years |
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: | P03735 |
Study First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00751218 |
Health Authority: | United States: Food and Drug Administration |
Hypersensitivity Skin Diseases Hypersensitivity, Immediate Histamine phosphate |
Urticaria Cetirizine Desloratadine Histamine |
Skin Diseases, Vascular Neurotransmitter Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Histamine Agents |
Anti-Allergic Agents Cholinergic Agents Pharmacologic Actions Histamine Antagonists Therapeutic Uses Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |