NCT01529242终止3 期
A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash
EMS3 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Efficacy of treatment in acute cutaneous rash based on symptoms score
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.
详细描述
- double-blind, non-inferiority, prospective, parallel group trial.
- Experiment duration: 05 days.
- 03 visits (day 0, 48 hours and day 5).
- Efficacy will be evaluated for acute cutaneous rash based on symptoms score
- Adverse events evaluation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent of the patient or legal guardian;
- •Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
- •Children aged between 2 and 11 years and 11 months (up to 30 kg);
排除标准
- •Participation in clinical trial in 30 days prior to study entry;
- •Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
- •Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
- •Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- •Patients diagnosed with other dermatoses
研究组 & 干预措施
Dexchlorpheniramine + Betamethasone
Active Comparator
dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution
干预措施: Dexchlorpheniramine + Betamethasone (Drug)
Desloratadine + Prednisolone
Experimental
desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution
干预措施: Desloratadine + Prednisolone (Drug)
结局指标
主要结局
Efficacy of treatment in acute cutaneous rash based on symptoms score
时间窗: 5 days
The differences in the intensity of signs and symptoms of acute cutaneous rash between the beginning and end of the study will be used as the primary endpoint of clinical efficacy .
次要结局
- Safety will be evaluated by the adverse event occurrences(5 days)
研究者
研究点 (3)
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