NCT00544388已完成3 期
Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).
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
- 570
- 主要终点
- Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
研究概览
简要总结
Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female, aged >= 16 years
- •seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
- •documented seasonal allergy to ragweed pollen
- •total symptom score of at least 18 points.
排除标准
- •nasal anatomic deformities ? 50% obstruction
- •acute sinusitis within 30 days of Period 2
- •initiated or advanced an immunotherapy regimen
- •immunotherapy injections within 48 hours of pollen exposure
- •impaired hepatic function
- •history of malignancy
- •intolerance to histamines
- •asthma requiring medication more than occasionally
结局指标
主要结局
Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
次要结局
- Mean change from baseline in MSC score over each 2-hour interval.
研究者
相似试验
已完成
4 期
CUTE (Chronic Urticaria Treatment Evaluation)Chronic Idiopathic UrticariaNCT00264303UCB Pharma886
已完成
2 期
A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed PollenAllergicSeasonalRhinitisNCT00291642UCB Pharma551
已完成
4 期
Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic SeizuresEpilepsy, Idiopathic GeneralizedNCT03940326Mazandaran University of Medical Sciences103
已完成
1 期
Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting ConditionsFastingNCT01506076Dr. Reddy's Laboratories Limited29
已完成
1 期
Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fed ConditionsHealthyNCT01506063Dr. Reddy's Laboratories Limited31