Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.

Completed

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Key information

Conditions

Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

About this study

Pediatric patients aged 1-5 years

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with allergic rhinitis or chronic idiopathic urticaria
Aged 1-5 years old
Caregiver's consent to participate

Exclusion criteria

Healthy individuals
Younger or older than the 1-5 year old age range

Treatment and study plan

desloratadine

Drug

2.5 ml (1.25 mg) once daily

Other names: Aerius, SCH 034117

Primary outcomes

Proportion of Patients With Adverse Events

Time frame: Follow-up visit at 3 - 5 weeks after treatment initiation

An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 29, 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