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Study Of Atopic Dermatitis In Pediatrics

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cetirizine Dry Syrup
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic, Pediatric, Dermatitis

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site

Outcomes

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

Full Information

First Posted
November 21, 2005
Last Updated
May 3, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00257569
Brief Title
Study Of Atopic Dermatitis In Pediatrics
Official Title
Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Atopic, Pediatric, Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
278 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetirizine Dry Syrup
Primary Outcome Measure Information:
Title
change in the severity of pruritus
Secondary Outcome Measure Information:
Title
-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site

12. IPD Sharing Statement

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Study Of Atopic Dermatitis In Pediatrics

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