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

Atopy Clinical Trial

Official title:

Multiple-Dose Safety and Tolerance Study of Desloratadine in Atopic Pediatric Subjects and Pediatric Subjects With Chronic Idiopathic Urticaria, Ages >=2 to <12 Years, Who Are Poor Metabolizers of Desloratadine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757562
• Other study ID #: P02994
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2002
• Est. completion date: October 1, 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 1, 2003
• Est. primary completion date: October 1, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopy
• Chronic Idiopathic Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• desloratadine
desloratadine syrup: 1.25 mg (2.5 mL) for subjects >=2 to <6 years, 2.5 mg (5 mL) for subjects >=6 to <12 years, orally once daily in the morning for 36 days.
• Placebo
placebo syrup: 2.5 mL for subjects >=2 to <6 years, 5 mL for subjects >=6 to <12 years, orally once daily in the morning for 36 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerance		Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).
Secondary	Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36.		Days 15 and Days 36