Status:
COMPLETED
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Dermatitis
Atopic
Eligibility:
All Genders
7-15 years
Phase:
PHASE3
Brief Summary
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
Detailed Description
This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the...
Eligibility Criteria
Inclusion
- Patients aged between 7 and 15 years
- Patients giving assent and whose legal guardian giving informed consent
- Outpatients
- Patients diagnosed as atopic dermatitis
- Patients who require the treatment with topical corticosteroid on areas other than face, head and neck
- Patients whose diaries can be properly maintained
- Patients who have 2 grades or more pruritus score
Exclusion
- Patients with bronchial asthma who require concomitant use of the corticosteroid
- Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy
- Patients with current or previous history of drug hypersensitivity
- Patients who have been treated with Bepotastine besilate in the past
- Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied
- Patients who have spastic disease such as epilepsy
- Patients who concurrently have renal function abnormalities that may cause safety problems
- Patients who do not give consent to use birth control
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients who had participated in any clinical trial in the last 12 weeks
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01840605
Start Date
March 1 2013
End Date
November 1 2013
Last Update
January 8 2026
Active Locations (1)
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1
Medical Corporation Kojinkai Asanuma Dermatology Clinic
Hokkaido, Japan