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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
History of Changes
  Purpose

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.


Condition Intervention
Rhinitis
Urticaria
 Drug: Desloratadine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric Patients
Those with allergic rhinitis or chronic idiopathic urticaria.
 Drug: Desloratadine
2.5 ml (1.25 mg) once daily
Other Names:
  • Aerius
  • SCH 034117

Detailed Description:

Pediatric patients aged 1-5 years

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric clinics around Hungary.

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00723736     History of Changes
Other Study ID Numbers: P04446
Study First Received: July 25, 2008
Results First Received: June 18, 2009
Last Updated: May 27, 2010
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Rhinitis
Urticaria
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on May 16, 2013