NCT00150761已完成4 期
A Randomized, Double-blind, Double Dummy, Placebo Controlled, Cross-over Exploratory Trial in Healthy Male Adult Subjects: Comparison by Means of Infrared Thermography of the Anti-H1 Potency of Levocetirizine 5 mg and Cetirizine 10 mg Tablet Single Oral Dose After Nasal Histamine Provocation.
适应症
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
- 60
- 主要终点
- To compare by means of infrared (IR) thermography the anti-histaminic potency of levocetirizine 5mg (single dose) and cetirizine 5mg (single dose) using a placebo as control following 2 nasal histamine provocations (NHP) performed respectively 10 minutes
研究概览
简要总结
Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male Caucasian subject aged between 18 and 55 years (both inclusive).
- •Subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/mL) and ≤ 3 mm with diluent control).
排除标准
- •History of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy.
- •Any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc.
- •History of hot flushes and any other vasomotor disorders.
- •ENT infection or Upper Respiratory Tract Infection not completely cured at least one week before inclusion.
- •Any known history of laryngeal edema.
- •Nasal structural abnormalities (e.g. deviation of the nasal septum...).
- •Recent immunotherapy
- •Skin irritants or UV exposure 48 hours before each visit.
结局指标
主要结局
To compare by means of infrared (IR) thermography the anti-histaminic potency of levocetirizine 5mg (single dose) and cetirizine 5mg (single dose) using a placebo as control following 2 nasal histamine provocations (NHP) performed respectively 10 minutes
次要结局
- To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg
- To explore predictive value of screening thermography parameters on treatment effect
- To collect additional safety information on levocetizine
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