NCT00757562

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Idiopathic Urticaria
• Atopy

Interventions

Type	Name	Description
DRUG	desloratadine	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.
DRUG	Placebo	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.

Timeline

• Start date: 2002-11-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2008-09-23
• Last updated: 2024-08-15