NCT00257569

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

First QC Date

November 21, 2005

Last Update Submit

May 3, 2013

Conditions

Dermatitis, Atopic

Keywords

AtopicPediatricDermatitis

Outcome Measures

Primary Outcomes (1)

  • change in the severity of pruritus

Secondary Outcomes (1)

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

Interventions

Cetirizine Dry SyrupDRUG

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Location

MeSH Terms

Conditions

Dermatitis, AtopicDermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

August 1, 2005

Last Updated

May 6, 2013

Record last verified: 2013-05