NCT02182570已完成3 期
Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)
研究概览
简要总结
The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in this study, subjects must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis will be conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis", issued by the Japanese Dermatological Association.
- •15 years of age or younger
- •Body weight of 14 kg or more
- •Outpatients
- •The patient has been undergoing treatment with a "very strong" or lower-grade external steroid preparation for >= 1 week at the time informed consent is obtained
- •Pruritus with "2" or higher grade at the start time of administration
排除标准
- •Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
- •Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
- •Use of any external steroid preparation at "Strongest" in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
- •Undergoing phototherapy
- •Undergoing specific desensitization therapy or modulation therapy
- •Past history of contact dermatitis caused by external steroid preparation
- •Possibility of exacerbation by an external steroid preparation of infectious skin disease caused by bacteria, fungi, or virus
- •Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient was ineligible for inclusion in this study. Patients must be excluded from the study if the patients fell under Grade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria
- •Past history of allergy to any drug
- •Participation in any other clinical study, or history of participation in any other clinical study within 6 months before the date when the patient gave consent to participate in this study
- •Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
研究组 & 干预措施
WAL 801 CL
Experimental
干预措施: WAL 801 CL dry syrup (Drug)
结局指标
主要结局
Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)
时间窗: Baseline, weeks 4, 8 and 12
Overall incidence of adverse events
时间窗: up to 12 weeks
次要结局
- Degree of rash(at weeks 4, 8 and 12)
- Pruritus score obtained through the itching questionnaire(at weeks 4, 8 and 12)
- Impression on pruritus of the patient or the parent(week 12)
- Degree of pruritus(at weeks 4, 8 and 12)
- Plasma concentration of epinastine hydrochloride(pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose)
研究者
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