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

NCT ID: NCT00757562

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-01
• Study Completion Date: 2003-10-01

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.

Conditions

Chronic Idiopathic Urticaria; Atopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DL

Desloratadine syrup once daily

Group Type: EXPERIMENTAL

desloratadine

Intervention Type: DRUG

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 once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

SCH 034117; Clarinex

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P02994

Identifier Type: -

Identifier Source: org_study_id