Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)

Organon and Co591 enrolled

Overview

Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.

Children, ages 2-11, with a history of perennial allergic rhinitis

Study Type

OBSERVATIONAL

Enrollment

591

Conditions

Rhinitis

Interventions

Desloratadine (assigned by investigator as part of normal practice)DRUG

Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children patients of both sexes aged between 2-11 years, of either gender and any race * Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation * Minimum score for inclusion: 10 * Capable of complying with the dosing regimen * Free of any clinically significant disease (other than allergic rhinitis) * Antihistamine must be justified by investigating doctor Exclusion Criteria: * Patients with asthma who require chronic use of inhaled or systemic corticosteroids * History of frequent, clinically significant sinusitis or chronic purulent postnasal drip * Patients with rhinitis medicamentosa * History of hypersensitivity to desloratadine or any of its excipients * Doctor deems unsuitable

Outcomes

Primary Outcomes

Adverse Events

An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.

Time frame: Minimum of 7 days after initiation of desloratadine

General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments

Physicians judged the subjects as good, excellent, fair, or poor.

Time frame: Minimum of 7 days after initiation of desloratadine

Data from ClinicalTrials.gov

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