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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00359138 |
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 |
MedlinePlus related topics: | Allergy |
Drug Information available for: | Levocetirizine dihydrochloride Levocetirizine Histamine Histamine dihydrochloride Histamine phosphate |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Medications Prohibited During the Trial and Washout Period Prior to Visit 1
Corticosteroids
Cromolyn/Lodoxamide/Nedocromil
Antihistamines
Decongestants
Tetracyclic antidepressants (eg, maprotiline, mirtazapine), 30 days
Study ID Numbers: | P04441 |
First Received: | July 31, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00359138 |
Health Authority: | European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency |
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