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

Organon

Status and phase

Completed

Phase 3

Conditions

Atopy

Chronic Idiopathic Urticaria

Treatments

Drug: Placebo

Drug: desloratadine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00757562

P02994

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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.