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

Completed

• Conditions: Rhinitis
• Interventions: Drug: Desloratadine (assigned by investigator as part of normal practice)

• Registration Number: NCT00704769
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Results First Submitted: 2009-03-12
• Results First Submitted QC: 2009-06-24
• Results First Posted: 2009-08-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Desloratadine (assigned by investigator as part of normal practice)	Children with a history of perennial allergic rhinitis

Primary Outcome Measures

Name	Time	Method
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments	Minimum of 7 days after initiation of desloratadine	Physicians judged the subjects as good, excellent, fair, or poor.
Adverse Events	Minimum of 7 days after initiation of desloratadine	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.