A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TAU-284	Bepotastine besilate	Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day, once after breakfast and once before bed.
ketotifen fumarate	ketotifen fumarate	Two TAU-284 5mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day, once after breakfast and once before bed.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pruritus Score	Baseline and 2 weeks	The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Pruritus Score	Baseline and 1 weeks	The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)	Baseline and 2 weeks	Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)	Week 2	Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).