Last updated: 11/03/2018 07:47:45
Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
GSK study ID
104915
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Chronic urticaria
- Eczema & dermatitis group
- have a history of drug hypersensitivity
- are pregnant, lactating or possibly pregnant female children.
Inclusion and exclusion 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)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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