N/A Completed N=100

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

Rhinitis · Urticaria

Source: ClinicalTrials.gov NCT00723736 ↗

Enrolled (actual)

100

Serious AEs

1.0%

Results posted

Aug 2009

Primary outcomePrimary: Proportion of Patients With Adverse Events — 20; 4; 21; 6 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With Adverse Events	20; 4; 21; 6; 4	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00723736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.