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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00723736
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : August 6, 2009
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Rhinitis Urticaria Drug: Desloratadine

Detailed Description:
Pediatric patients aged 1-5 years

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
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.
Study Start Date : December 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of Patients With Adverse Events [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723736     History of Changes
Other Study ID Numbers: P04446
First Posted: July 29, 2008    Key Record Dates
Results First Posted: August 6, 2009
Last Update Posted: April 30, 2015
Last Verified: April 2015

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