Last updated: 11/03/2018 07:47:09
Study Of Atopic Dermatitis In Pediatrics
GSK study ID
104913
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Children diagnosed as atopic dermatitis
- Giving informed consent
- have spastic disease such as epilepsy
- have a history of drug hypersensitivity
Inclusion and exclusion 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)
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
2006-28-01
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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