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

This study has been completed.

First Received: March 28, 2007 Last Updated: September 11, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00453583

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:	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:

MedlinePlus related topics: Allergy Cold and Cough Medicines

Drug Information available for: Histamine Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine citrate Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Parent satisfaction on a 11-point scale [ Time Frame: duration of the study ]

Secondary Outcome Measures:

Physician satisfaction on an 11-point scale [ Time Frame: duration of the study ]
Efficacy, tolerability and global satisfaction [ Time Frame: duration of the study ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	A00420
Study First Received:	March 28, 2007
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00453583 History of Changes
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:

Neurotransmitter Agents
Hypersensitivity
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases

Physiological Effects of Drugs
Histamine Agents
Histamine H1 Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010