Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous Disease; Pruritus
Intervention: Cetirizine Dry Syrup (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
To assess the safety of long-term use of cetirizine dry syrup in children with various type
of cutaneous disease accompanied on pruritus.
Clinical Details
Official title: Long-Term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To assess the safety
Secondary outcome: -severity of pruritus
-total pruritus score
-daily main prurutus score
-Severity of eruption
-Patient global Improvement rating
-Body temperature
-Adverse events
-Cetirizine serum concentrations
Eligibility
Minimum age: 2 Years.
Maximum age: 14 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Hokkaido_1 066, Japan
GSK Clinical Trials Call Center, Hokkaido_2 060, Japan
GSK Clinical Trials Call Center, Hokkaido_3 061, Japan
GSK Clinical Trials Call Center, Hokkaido_14 093, Japan
GSK Clinical Trials Call Center, Saitama_15 359, Japan
GSK Clinical Trials Call Center, Tokyo_16 166, Japan
GSK Clinical Trials Call Center, Tokyo_17 157, Japan
GSK Clinical Trials Call Center, Tokyo_18 158, Japan
GSK Clinical Trials Call Center, Fukuoka_23 814, Japan
GSK Clinical Trials Call Center, Fukuoka_24 819, Japan
GSK Clinical Trials Call Center, Fukuoka_25 819, Japan
GSK Clinical Trials Call Center, Hokkaido_4 069, Japan
GSK Clinical Trials Call Center, Hokkaido_5 066, Japan
GSK Clinical Trials Call Center, Hokkaido_6 062, Japan
GSK Clinical Trials Call Center, Hokkaido_8 003, Japan
GSK Clinical Trials Call Center, Hokkaido_11 061, Japan
GSK Clinical Trials Call Center, Hokkaido_12 079, Japan
GSK Clinical Trials Call Center, Hokkaido_13 090, Japan
GSK Clinical Trials Call Center, Kanagawa_19 245, Japan
GSK Clinical Trials Call Center, Fukuoka_20 814, Japan
GSK Clinical Trials Call Center, Fukuoka_21 814, Japan
GSK Clinical Trials Call Center, Fukuoka_22 813, Japan
Additional Information
Starting date: July 2005
Last updated: July 31, 2007
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