Study Of Atopic Dermatitis In Pediatrics

NCT ID: NCT00257569

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cetirizine Dry Syrup

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

, ,

Site Status

Countries

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Other Identifiers

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104913

Identifier Type: -

Identifier Source: org_study_id

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