Clinical trial NCT01840605: A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
Official title: A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis
Atopic
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 303
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Pruritus Score
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change From Baseline in Pruritus Score
timeFrame: Baseline and 1 weeks
measure: Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
timeFrame: Baseline and 2 weeks
measure: Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
timeFrame: Week 2
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: Medical Corporation Kojinkai Asanuma Dermatology Clinic
Study officials:
affiliation: Tokyo Women's Medical University
name: MAKOTO KAWASHIMA
role: STUDY_DIRECTOR
References:
citation: Kawashima M; Ichimura M; Yano K; Susuta Y; Izaki H. Phase III study of bepotastine besilate in children with atopic dermatitis -A randomized, double-blind, parallel-group, comparative study with ketotifen fumarate dry syrup- Rinsho iyaku 2015 Mar;31(3):235-251