Study Of Atopic Dermatitis In Pediatrics

This study has been completed.

First Received on November 21, 2005. Last Updated on October 5, 2010 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00257569

Purpose

To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Cetirizine Dry Syrup	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

Resource links provided by NLM:

MedlinePlus related topics: Itching

Drug Information available for: Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

change in the severity of pruritus

Secondary Outcome Measures:

-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events

Estimated Enrollment:	278
Study Start Date:	August 2005
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Cetirizine Dry Syrup

Eligibility

Ages Eligible for Study:	3 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children diagnosed as atopic dermatitis
Giving informed consent
Children who have 2 grades or more pruritus score.
Children who require the treatment with external steroid preparation other than face and head.
Children with a pruritus severity of 2.
Mild or severe on the fist day of the treatment period.

Exclusion criteria:

have spastic disease such as epilepsy
have a history of drug hypersensitivity
are lactating or possibly pregnant female Children
have a skin infection, or with zooparasite such as scabies and pediculosis
cannot avoid the use of external steroid classified into strong, strongest or very strong
have eczematous otitis externa with perforation in the eardrum
have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
have asthma that requires the treatment with corticosteroid
have pruritus only on face and head
have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug
are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257569

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00257569 History of Changes
Other Study ID Numbers:	104913, RPCE04E1102/A00387
Study First Received:	November 21, 2005
Last Updated:	October 5, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Atopic
Dermatitis
Pediatric

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine

Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012