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

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 Overview

• Status: Completed
• Conditions: Rhinitis
• Intervention / Treatment: Drug: Desloratadine (assigned by investigator as part of normal practice)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 591

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Children with a history of perennial allergic rhinitis	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; Other Names: SCH 034117

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: June 23, 2008
• First Submitted That Met QC Criteria: June 23, 2008
• First Posted (Estimate): June 25, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Desloratadine
• Other Study ID Numbers: P04299