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临床试验/NCT00525278
NCT00525278已完成3 期

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 Seasonal Allergic Rhinitis (SAR)

UCB Pharma0 个研究点目标入组 67 人开始时间: 2003年8月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
UCB Pharma
入组人数
67
主要终点
Investigator rated T5SS (Total 5 symptom Score) over 2 weeks

研究概览

简要总结

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

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
Single

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, 18 to 60 years old, inclusive
  • two-year history of allergic rhinitis due to tree, grass or weed pollen
  • sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

排除标准

  • An ear, nose or throat (ENT) infection
  • asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
  • atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
  • an associated ENT disease
  • use of decongestants
  • nasal or ocular topical treatment

结局指标

主要结局

Investigator rated T5SS (Total 5 symptom Score) over 2 weeks

时间窗: 2 weeks

次要结局

  • Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI).(2 weeks)

研究者

发起方
UCB Pharma
申办方类型
Industry

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