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

Phase 3

Completed

• Conditions: Chronic Idiopathic Urticaria; Atopy
• Interventions: Drug: Placebo; Drug: desloratadine

• Registration Number: NCT00757562
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11-01
• Primary Completion: 2003-10-01
• Study Completion: 2003-10-01
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo syrup once daily
DL	desloratadine	Desloratadine syrup once daily

Primary Outcome Measures

Name	Time	Method
Safety and Tolerance	Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).

Secondary Outcome Measures

Name	Time	Method
Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36.	Days 15 and Days 36