Last updated: 11/03/2018 07:47:45

Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

GSK study ID
104915
Clinicaltrials.gov ID
NCT00257582
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: Long-term Study of Cetirizine Dry Syrup in Children suffering from Various Type of Cutaneous Disease Accompanied with Pruritus.
Trial description: To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Cetirizine Dry Syrup
    • Enrollment:
    60
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pruritus
    Product
    cetirizine
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to March 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 14 years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Chronic urticaria
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Chronic urticaria
    • Eczema & dermatitis group
    • Atopic dermatitis
    • Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
    • Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
    • Giving informed consent
    • Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
    • Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period. Exclusion criteria:
    • have a history of drug hypersensitivity
    • are pregnant, lactating or possibly pregnant female children.
    • have asthma that requires the treatment with corticosteroid.
    • cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
    • 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
    2006-22-03

    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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