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| Sponsored by: |
Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00359138 |
Purpose
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypersensitivity |
Drug: desloratadine Drug: levocetirizine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Randomized Study to Assess the Duration of the Suppressive Effects of Desloratadine on the Cutaneous Allergen-Induced Wheal and Flare (1) Response After Discontinuation |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below. Medications Prohibited During the Trial and Washout Period Prior to Visit 1
Corticosteroids
Cromolyn/Lodoxamide/Nedocromil
Antihistamines
Decongestants
Contacts and Locations
More Information
| Study ID Numbers: | P04441 |
| Study First Received: | July 31, 2006 |
| Last Updated: | November 16, 2006 |
| ClinicalTrials.gov Identifier: | NCT00359138 History of Changes |
| Health Authority: | European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency |
|
Histamine H1 Antagonists Anti-Allergic Agents |
|
Neurotransmitter Agents Hypersensitivity Histamine Antagonists Cholinergic Antagonists Levocetirizine Histamine phosphate |
Histamine H1 Antagonists Anti-Allergic Agents Cholinergic Agents Desloratadine Histamine |
|
Neurotransmitter Agents Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Cholinergic Agents |
Desloratadine Pharmacologic Actions Hypersensitivity Histamine Antagonists Levocetirizine Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |