Overview

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

Status:
Completed
Trial end date:
2003-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Desloratadine
Loratadine
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.