NCT00851344已完成2 期
A Randomised, Double-blind, Placebo-controlled, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change from baseline in total nasal symptom score 0-4 hours post dose
研究概览
简要总结
A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- •Aged 18 - 60
- •Weight 50kg+, BMI 19-32 kg/m2
- •Exhibit response to Challenge Chamber and skin prick test.
- •Non-smoker
- •Capable of giving informed consent
排除标准
- •No nasal structural abnornmality/polyposis, surgery, infection.
- •any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- •participated in another clinical study within 30 days.
- •Subject has donated a unit of blood within 1 month
- •Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- •History of sensitivty to drug
- •History of alcohol/drug abuse within 12 months.
- •Positive Hepatitis B antibody test
- •Positive HIV antibody test
- •Risk of non-compliance with study protocol
- •Perenial allergic rhinitis
- •Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
- •Past or present disease that may affect outcome, as judge by investigator
- •Specific Immunotherapy within 2 years
研究组 & 干预措施
GSK835726 (10mg)
Active Comparator
10mg oral dose
干预措施: GSK835726 (10mg) (Drug)
GSK835726 (50mg)
Active Comparator
50mg oral dose
干预措施: GSK835726 (50mg) (Drug)
GSK835726 (100mg)
Active Comparator
50mg oral dose
干预措施: GSK835726 (100mg) (Drug)
Cetirizine 10mg
Active Comparator
10mg cetirizine as active comparator
干预措施: Cetirizine (10mg) (Drug)
placebo
Placebo Comparator
placebo tablet
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in total nasal symptom score 0-4 hours post dose
时间窗: 0-4 hours post dose
次要结局
未报告次要终点
研究者
研究点 (1)
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