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| Sponsor: | 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 Drug: Desloratadine placebo tablet Drug: Levocetirizine placebo capsule |
Phase IV |
| 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: | 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 |
| Enrollment: | 36 |
| Study Start Date: | February 2006 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Desloratadine 5 mg tablet + Levocetirizine placebo capsule
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Drug: desloratadine
5 mg tablet once daily
Drug: Levocetirizine placebo capsule
once daily
|
|
Active Comparator: Desloratadine placebo tablet + Levocetirizine 5 mg capsule
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Drug: levocetirizine
5 mg capsule once daily
Drug: Desloratadine placebo tablet
once daily
|
|
Placebo Comparator: Desloratadine placebo tablet + Levocetirizine placebo capsule
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Drug: Desloratadine placebo tablet
once daily
Drug: Levocetirizine placebo capsule
once daily
|
Eligibility| 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
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00359138 History of Changes |
| Other Study ID Numbers: | P04441 |
| Study First Received: | July 31, 2006 |
| Results First Received: | May 27, 2010 |
| Last Updated: | December 17, 2010 |
| Health Authority: | European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency |
|
Histamine H1 Antagonists Anti-Allergic Agents |
|
Hypersensitivity Immune System Diseases Histamine H1 Antagonists Desloratadine Loratadine Levocetirizine Cetirizine Anti-Allergic Agents Histamine Antagonists Histamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Cholinergic Antagonists Cholinergic Agents Histamine H1 Antagonists, Non-Sedating Antipruritics Dermatologic Agents |