Status:
COMPLETED
Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pruritus
Eligibility:
All Genders
2-14 years
Phase:
PHASE3
Brief Summary
To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00257582
Start Date
August 1 2005
Last Update
May 6 2013
Active Locations (1)
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1
GSK Investigational Site