Study Of Atopic Dermatitis In Pediatrics

May 3, 2013 updated by: GlaxoSmithKline

Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in the severity of pruritus

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (Estimate)

November 23, 2005

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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