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

NCT00757562 | Completed Phase 3

• 1 other identifier: P02994
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerance

  Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).

Secondary Outcomes (1)

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

  Days 15 and Days 36

Study Arms (2)

DL

EXPERIMENTAL

Desloratadine syrup once daily

Drug: desloratadine

Placebo

PLACEBO COMPARATOR

placebo syrup once daily

Drug: Placebo

Interventions

desloratadine 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.

Also known as: SCH 034117, Clarinex

DL

Placebo 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.

Placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Chronic Urticaria

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: November 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: August 15, 2024

Record last verified: 2022-02