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NCT00723736 Clinical Trial

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

Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00723736
Other study ID # P04446
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2007
Est. completion date June 2008

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Pediatric patients aged 1-5 years

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 1 Year to 5 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Desloratadine
2.5 ml (1.25 mg) once daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Patients With Adverse Events 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. Follow-up visit at 3 - 5 weeks after treatment initiation
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