Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00453583
First received: March 28, 2007
Last updated: December 13, 2013
Last verified: May 2012
  Purpose

This is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an H1-antihistamine. The period of last taken medication will be observed to evaluate the global satisfaction of the parents and physician for this last treatment.


Condition
Allergies

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Evaluation of the Treatment Satisfaction in Children Suffering From an Allergy and Who Received an Antihistamine Treatment

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Parent satisfaction on a 11-point scale [ Time Frame: duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician satisfaction on an 11-point scale [ Time Frame: duration of the study ] [ Designated as safety issue: No ]
  • Efficacy, tolerability and global satisfaction [ Time Frame: duration of the study ] [ Designated as safety issue: No ]

Enrollment: 4581
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care

Criteria

Inclusion Criteria:

  • Children from 2-12 included
  • History of allergy
  • Used an Antihistamine within market authorization

Exclusion Criteria:

  • Child not yet treated for the presented allergy
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453583

Locations
United States, Georgia
UCB Pharma
Smyrna, Georgia, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00453583     History of Changes
Other Study ID Numbers: A00420
Study First Received: March 28, 2007
Last Updated: December 13, 2013
Health Authority: European Union: European Medicines Agency
South Korea: Korea Food and Drug Administration (KFDA)
India: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Spain: Spanish Agency of Medicines

Keywords provided by UCB, Inc.:
Pediatric
Allergies
Antihistamines
Non-interventional

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014