A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pruritus Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TAU-284
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.
干预措施: Bepotastine besilate (Drug)
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.
干预措施: ketotifen fumarate (Drug)
结局指标
主要结局
Change From Baseline in Pruritus Score
时间窗: Baseline and 2 weeks
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
次要结局
- Change From Baseline in Pruritus Score(Baseline and 1 weeks)
- Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)(Baseline and 2 weeks)
- Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)(Week 2)