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.