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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757562

Enrollment

Registered

2008-09-23

Start date

2002-11-01

Completion date

2003-10-01

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopy, Chronic Idiopathic Urticaria

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.

Interventions

DRUGdesloratadine

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.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026