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

Completed

• Conditions: Rhinitis; Urticaria
• Interventions: Drug: Desloratadine

• Registration Number: NCT00723736
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Pediatric patients aged 1-5 years

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Results First Submitted: 2009-06-18
• Results First Submitted QC: 2009-06-18
• Results First Posted: 2009-08-06
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Patients	Desloratadine	Those with allergic rhinitis or chronic idiopathic urticaria.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Adverse Events	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.