Official Title: “Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients”

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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: December 2007

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

Intervention(s) in this Clinical Trial

• Drug: Desloratadine
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Children with a history of perennial allergic rhinitis

Primary Measures

• Adverse Events
  • Time Frame: Visits 1 & 2
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00704769

Study ID Number: P04299

ClinicalTrials.gov Identifier: NCT00704769

Health Authority: Indonesia: National Agency of Drug and Food Control