A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)

UCB Pharma0 个研究点目标入组 134 人开始时间: 2003年8月最近更新: 2013年12月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: UCB Pharma
入组人数: 134
主要终点: pruritus severity, assessed by the investigator over 2 weeks of treatment

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.

•Male or female, 18 to 60 years old (inclusive
•having chronic idiopathic urticaria
•at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
•moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization

•Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
•atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids
•urticaria caused by physical factors or other known factors
•cholinergic urticaria
•had urticaria due to other systemic disorders
•were on antihistamine drug currently

pruritus severity, assessed by the investigator over 2 weeks of treatment

时间窗: 2 weeks

Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety(2 weeks)

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