NCT01651871已完成2 期
A Phase 2, Multicenter, Parallel-Group, Randomized, Double-Blind, Placebo- And Active Comparator-Controlled, Combination Study Of S-555739 And Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Shionogi0 个研究点目标入组 779 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 779
- 主要终点
- Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History and diagnosis of seasonal allergic rhinitis by skin prick test
- •Have nasal symptom scores as defined by the study protocol
- •Able to comply with study procedures
排除标准
- •Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
- •Use of any prohibited concomitant drugs or therapies
研究组 & 干预措施
Treatment Group 2
Experimental
干预措施: Cetirizine HCl Dose 1 (Drug)
Treatment Group 1
Experimental
干预措施: S-555739 Dose 1 (Drug)
Treatment Group 1
Experimental
干预措施: Cetirizine HCl Dose 1 (Drug)
Treatment Group 2
Experimental
干预措施: S-555739 Dose 2 (Drug)
Treatment Group 2
Experimental
干预措施: S-555739 placebo (Drug)
Treatment Group 3
Experimental
干预措施: S-555739 Dose 1 (Drug)
Treatment Group 3
Experimental
干预措施: Cetirizine HCl placebo (Drug)
Treatment Group 4
Active Comparator
干预措施: Cetirizine HCl Dose 1 (Drug)
Treatment Group 4
Active Comparator
干预措施: S-555739 placebo (Drug)
Treatment Group 5
Placebo Comparator
干预措施: S-555739 placebo (Drug)
Treatment Group 5
Placebo Comparator
干预措施: Cetirizine HCl placebo (Drug)
结局指标
主要结局
Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
时间窗: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Incidence of adverse events (AEs)
时间窗: From Screening period to Week 6 (Follow-up)
次要结局
- Change in average AM/PM Total Ocular Symptom Score(Change from baseline through the 2-week treatment period (Day 2 through Day 15))
- Assessment of Quality of Life(Change from Week 3 to Week 5)
- Assessment of clinical laboratory parameters(At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up))
- Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS)(Change from baseline through the 2-week treatment period (Day 2 through Day 15))
- Assessment of vital signs(At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5)
- Assessment of electrocardiogram (ECG) findings(At Week 1 (Screening) and Week 5)
研究者
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