drugset / Trial / NCT00757562

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

NCT00757562

Phase 3 Completed 97 enrolled Organon and Co
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2002-11-01
Primary completion
2003-10-01
Completion
2003-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Desloratadine Small molecule 1.25 mg Oral
Subject Desloratadine Small molecule 2.5 mg Oral