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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00723736
First received: July 25, 2008
Last updated: May 2, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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 2, 2014
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on October 20, 2014