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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Bepotastine besilate
* Drug: ketotifen fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU-284<br>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. | Drug: Bepotastine besilate<br>* Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day<br>* Other names: TALION 5mg tablets;|
| Active Comparator: ketotifen fumarate<br>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. | Drug: ketotifen fumarate<br>* Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day<br>* Other names: ketotifen fumarate dry syrup;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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