Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)

Study Overview
=================
Brief Summary
-----------------
This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.

Official Title
-----------------
Multiple-Dose Safety and Tolerance Study of Desloratadine in Atopic Pediatric Subjects and Pediatric Subjects With Chronic Idiopathic Urticaria, Ages >=2 to <12 Years, Who Are Poor Metabolizers of Desloratadine

Conditions
-----------------
Chronic Idiopathic Urticaria, Atopy

Intervention / Treatment
-----------------
* Drug: desloratadine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must: have been previously identified through the previous study P03031 to be atopic or with chronic idiopathic urticaria and be a poor metabolizer of desloratadine. have clinical laboratory tests within normal limits. be in good health, free of any clinically significant disease that could interfere with the study. normal 12-lead ECG Exclusion Criteria: Subjects who: have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to treatment. have taken any medication that is restricted by the protocol or failed to satisfy washout requirements. are allergic to desloratadine. have used a loratadine- or desloratadine-containing product within the past 30 days. are female and menstruating.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DL<br>Desloratadine syrup once daily | Drug: desloratadine<br>* desloratadine syrup: 1.25 mg (2.5 mL) for subjects >=2 to <6 years, 2.5 mg (5 mL) for subjects >=6 to <12 years, orally once daily in the morning for 36 days.<br>* Other names: Clarinex;|
| Placebo Comparator: Placebo<br>placebo syrup once daily | Drug: Placebo<br>* placebo syrup: 2.5 mL for subjects >=2 to <6 years, 5 mL for subjects >=6 to <12 years, orally once daily in the morning for 36 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerance |  | Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36. |  | Days 15 and Days 36 |