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

Rhinitis Clinical Trial

Official title:

Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704769
• Other study ID #: P04299
• Status: Completed
• Start date: May 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Minimum of 7 days after initiation of desloratadine
Primary	General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments	Physicians judged the subjects as good, excellent, fair, or poor.	Minimum of 7 days after initiation of desloratadine