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

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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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desloratadine (assigned by investigator as part of normal practice)

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

Other names: SCH 034117

Primary outcomes

Adverse Events

Time frame: 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.
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments

Time frame: Minimum of 7 days after initiation of desloratadine

Physicians judged the subjects as good, excellent, fair, or poor.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Jun 25, 2008
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed