Last updated: 11/03/2018 07:47:09

Study Of Atopic Dermatitis In Pediatrics

GSK study ID
104913
Clinicaltrials.gov ID
NCT00257569
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering from Atopic Dermatitis-
Trial description: To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Cetirizine Dry Syrup
    • Enrollment:
    278
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dermatitis, Atopic
    Product
    cetirizine
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to January 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    3 - 14 years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Children diagnosed as atopic dermatitis
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Japan
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-28-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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