Skip_to_Main_Content [ClinicalTrials.gov] Home Search Study_Topics Glossary [term ] [Search]   Full     Contacts   No_Study   Text View Tabular and_Locations Results Related   View     Posted   Studies   The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (Study P04441)(COMPLETED) This study has been completed. ______________________________________________ |_________________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 |Phase IV| |________________|Drug:_levocetirizine|________| MedlinePlus related topics: Allergy Drug_Information available for: Levocetirizine dihydrochloride Levocetirizine Histamine Histamine dihydrochloride Histamine phosphate U.S._FDA_Resources 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 Further study details as provided by Schering-Plough: Estimated Enrollment: 36 Study Start Date: February 2006   Eligibility Ages Eligible for Study:   18 Years and older Genders Eligible for Study:  Both Accepts Healthy Volunteers:  No Criteria Inclusion Criteria: * Subjects must be 18 years of age or older, of either sex. * Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander. * Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season. * Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Subjects must understand and be able to adhere to visit schedules * Subjects must be in general good health. * Women of child-bearing potential must have a negative pregnancy test at Day -1 and must use an accepted method of contraception during the entire duration of the study. Exclusion Criteria: * Subjects who have persistent asthma. * Subjects who have chronic urticaria or atopic dermatosis. * 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 o Intramuscular or intra-articular, 1 month o Oral, inhaled, intravenous, rectal, intranasal, or ocular, 7 days o High-potency dermatological, 7 days * Cromolyn/Lodoxamide/Nedocromil o Intranasal, ocular, inhaled, or oral, 2 days * Antihistamines o Long-acting prescription (eg, levocetirizine, fexofenadine, and desloratadine), 15 days o Short-acting (eg, chlorpheniramine, bromepheniramine including over-the-counter [OTC] forms, hydroxyzine), 15 days o Ocular (eg, levocabastine), 15 days * Leukotriene inhibitors (eg, montelukast), 7 days * Systemic antibiotics, 14 days (the washout refers to antibiotics used to treat an upper or lower respiratory tract infection) * Immunotherapy (desensitization), 1 year * Decongestants o oral, 2 days o local, 2 days * Ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs; eg, Toradol), 5 days * Investigational medications, 30 days * Tricyclic antidepressants (eg, amitriptyline, clomipramine, doxepin, imipramine, trimipramine, amoxapine, desipramine, nortriptyline, protriptyline), 30 days * Tetracyclic antidepressants (eg, maprotiline, mirtazapine), 30 days o Subjects with a history of hypersensitivity to desloratadine, to levocetirizine, or any of their excipients. o Women who are breast-feeding, pregnant, or intend to become pregnant. o Subjects with any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. o Subjects who have used any investigational drugs within 30 days of randomization. o Subjects working between 11 PM and 8 AM (night shift). o Subjects who have skin/color pigmentation incompatible with accurate measurements of flare reaction. o Subjects with cutaneous hyperactivity: negative prick test control >3 mm. o Subjects who are participating in any other clinical study. o Subjects who are part of the staff personnel directly involved with this study.   Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00359138 Sponsors and Collaborators Schering-Plough Investigators Principal Investigator: Study Principal Investigator Therapharm Recherches   More Information Study ID Numbers: P04441 Study First July 31, 2006 Received: Last Updated: November 16, 2006 ClinicalTrials.gov NCT00359138   Identifier: Health Authority: European Union: European Medicines Agency;   France: Afssaps - French Health Products Safety Agency Keywords provided by Schering-Plough: Histamine H1 Antagonists Anti-Allergic Agents Study placed in the following topic categories: Hypersensitivity Levocetirizine Histamine phosphate Desloratadine Histamine Additional relevant MeSH terms: Histamine H1 Antagonists, Non-Sedating Immune System Diseases Histamine H1 Antagonists Physiological Effects of Drugs Neurotransmitter Agents Histamine Agents Histamine Antagonists Cholinergic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Antagonists ClinicalTrials.gov processed this record on February 05, 2009 Back_to_top_of_Main_Content U.S._National_Library_of_Medicine,  Contact_Help_Desk U.S._National_Institutes_of_Health,  U.S._Department_of_Health_&_Human Services, USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom_of_Information_Act [U.S._National_Institutes_of_Health] [U.S._National_Library_of_Medicine] [U.S. Department_of_Health_&_Human_Services] Links_to_all_studies_-_primarily_for_crawlers