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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

591 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Children with a history of perennial allergic rhinitis

Desloratadine (assigned by investigator as part of normal practice)

Intervention Type 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

Interventions

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Desloratadine (assigned by investigator as part of normal practice)

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

Intervention Type DRUG

Other Intervention Names

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SCH 034117

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No