NCT00574379已完成2 期
A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen
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
- 805
- 试验地点
- 13
- 主要终点
- Change in nasal symptom scores
研究概览
简要总结
Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
- •documentation of a positive skin test within one year of screening to Mountain Cedar allergen
排除标准
- •significant medical condition
- •significant nasal abnormality
- •significant cardiac condition
- •recent infection
- •use of other allergy medication during the study
研究组 & 干预措施
1
Experimental
Bilastine 20mg once per day
干预措施: Bilastine (Drug)
2
Experimental
Bilastine 20mg twice per day
干预措施: Bilastine (Drug)
3
Experimental
Bilastine 10mg once per day
干预措施: Bilastine (Drug)
4
Experimental
Bilastine 10mg twice per day
干预措施: Bilastine (Drug)
5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in nasal symptom scores
时间窗: 14 days
次要结局
- Change in ocular symptom scores and quality of life scores; standard safety assessments(14 days)
研究者
研究点 (13)
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