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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00723736
First received: July 25, 2008
Last updated: May 27, 2010
Last verified: May 2010

July 25, 2008
May 27, 2010
December 2007
June 2008   (final data collection date for primary outcome measure)
Proportion of Patients With Adverse Events [ Time Frame: Follow-up visit at 3 - 5 weeks after treatment initiation ] [ Designated as safety issue: Yes ]
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.
Adverse Events [ Time Frame: Follow-up visit a few weeks after treatment initiation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00723736 on ClinicalTrials.gov Archive Site
Not Provided
Joint Parent/Child Global Therapeutic Response [ Time Frame: Follow-up visit a few weeks after treatment initiation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)
Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.

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.

Pediatric patients aged 1-5 years

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pediatric clinics around Hungary.

  • Rhinitis
  • Urticaria
Drug: Desloratadine
2.5 ml (1.25 mg) once daily
Other Names:
  • Aerius
  • SCH 034117
Pediatric Patients
Those with allergic rhinitis or chronic idiopathic urticaria.
Intervention: Drug: Desloratadine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
1 Year to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00723736
P04446
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP