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

Last updated: August 13, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Urticaria

Allergy (Pediatric)

Allergy

Treatment

Placebo

desloratadine

Clinical Study ID

NCT00757562
P02994
  • Ages 2-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects must:

  • have been previously identified through the previous study P03031 to be atopic orwith 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 interferewith the study.

  • normal 12-lead ECG

Exclusion

Exclusion Criteria:

Subjects who:

  • have a history of any clinically significant local or systemic infectious diseasewithin 4 weeks prior to treatment.

  • have taken any medication that is restricted by the protocol or failed to satisfywashout requirements.

  • are allergic to desloratadine.

  • have used a loratadine- or desloratadine-containing product within the past 30 days.

  • are female and menstruating.

Study Design

Total Participants: 97
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 01, 2002
Estimated Completion Date:
October 01, 2003