The Efficacy of Claritin in Healthy Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Change in Wheal Reaction Area From Baseline --- 2 Hour
研究概览
简要总结
The primary goal of this study is to examine determinants of the efficacy of Claritin.
详细描述
Subjects will be given Claritin 10mg tablet. Subjects will be challenged with histamine via skin prick prior to Claritin administration and at 1 and 2 hours post administration. We will measure and record wheal and flare area 10 minutes following each challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Claritin ads
Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.
干预措施: Claritin (Drug)
Zyrtec ads
Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.
干预措施: Claritin (Drug)
结局指标
主要结局
Change in Wheal Reaction Area From Baseline --- 2 Hour
时间窗: baseline and 2 hours post administration of Claritin.
A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 2 hours post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2.
次要结局
- Change in Wheal Reaction Area From Baseline --- 1 Hour(baseline and 1 hours post administration of Claritin)