NCT00264303已完成4 期
A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 886
- 主要终点
- Mean Pruritus Severity Score Over the First Week of Treatment
研究概览
简要总结
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause
- •At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.
排除标准
- •Any condition that would interfere with the evaluation of the therapeutic response.
研究组 & 干预措施
Levocetirizine
Experimental
Levocetirizine, once daily, 4 week duration
干预措施: Levocetirizine (Drug)
Desloratadine
Active Comparator
Desloratadine, once daily, 4 week duration
干预措施: Desloratadine (Drug)
结局指标
主要结局
Mean Pruritus Severity Score Over the First Week of Treatment
时间窗: over the first week of treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.
次要结局
- Mean Score for Pruritus Duration Over the First Week of Treatment(over the first week of treatment)
- Mean Score for Pruritus Duration Over the Four Weeks of Treatment(over the four weeks of treatment)
- Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment(over the first week of treatment)
- Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment(over the four weeks of treatment)
- Mean Pruritus Severity Score Over the Four Weeks of Treatment(over the four weeks of treatment)
研究者
相似试验
已完成
4 期
POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)Seasonal Allergic RhinitisNCT00160537UCB Pharma200
已完成
4 期
LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)Rhinitis, Allergic, PerennialNCT00160589UCB Pharma729
已完成
3 期
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic UrticariaUrticariaNCT00525382UCB Pharma134
已完成
3 期
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic RhinitisAllergicSeasonalRhinitisNCT00525278UCB Pharma67
Unknown
4 期
The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic UrticariaUrticariaChronic Idiopathic UrticariaNCT00346606Lotus Pharmaceutical60