NCT00817076已完成3 期
Evaluation of the Efficacy and Safety of Desloratadine Syrup in Childhood Atopic Dermatitis
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
- 40
- 主要终点
- Demonstration of the efficacy of desloratadine in relieving the total symptoms of atopic dermatitis through SCORAD Index
研究概览
简要总结
The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is called SCORAD. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must be from >= 6 to < 12 years of age, of either sex and any race.
- •Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent.
- •Children must be in general good health; i.e. they must be free of any clinically significant disease other than atopic dermatitis (AD) that would interfere with study evaluations.
- •Children's parent(s) or legal representative(s) must understand and be able to adhere to the dosing and visit schedule, and agree to report concomitant medications and adverse events to the Investigator or designee.
- •The diagnosis of AD will be performed according the Hanifin and Rajka criteria (Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol (Stockhr) 92 (suppl): 44-70, 1980): to be included in this study, children needed to manifest at least 3 major features and 3 minor features at visit 1 (day 1).
- •Children must be clinically symptomatic with AD at visit 1 (day 1). Disease severity will be estimated using the SCORAD Index (European task force on atopic dermatitis. Severity scoring of atopic dermatitis: the SCORAD Index. Dermatology 186: 23-31, 1993), and child must have a SCORAD Index at least >= 35.
排除标准
- •Children who have not observed the designated washout period for any of the prohibited medications.
- •Children with bronchial asthma who require chronic use of inhaled or systemic corticosteroids.
- •Children with a history of hypersensitivity to desloratadine, or any of its excipients.
- •Children who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, hepatic, renal, psychiatric, or cerebrovascular, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect children safety.
- •A known lack or response to H1-antihistamines.
研究组 & 干预措施
1
Experimental
干预措施: desloratadine (Drug)
结局指标
主要结局
Demonstration of the efficacy of desloratadine in relieving the total symptoms of atopic dermatitis through SCORAD Index
时间窗: Baseline, Day 8, Day 15, and Day 29
次要结局
- Evaluate the number of adverse events during therapy(Day 8, Day 15, and Day 29)
- The percent of subjects who rate their response to desloratadine as either Complete, Marked, or Moderate Relief(Day 8, Day 15, and Day 29)
研究者
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