NCT01241214已完成2 期
A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients 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
- 579
- 试验地点
- 7
- 主要终点
- To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
研究概览
简要总结
This study will assess the efficacy and safety of different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18 to 70 years.
- •Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years.
- •Adequate exposure to mountain cedar pollen.
- •Positive skin prick test to mountain cedar allergen within 12 months of screening.
- •Sufficient nasal symptom score during a run-in period.
排除标准
- •Non-allergic rhinitis.
- •Bacterial or viral respiratory tract infection.
- •Chronic respiratory disorders.
- •Asthma requiring treatment other than inhaled short-acting Beta2-agonists.
- •Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation.
- •Smoking within the last year.
- •Ongoing or recent treatment for seasonal allergic rhinitis.
- •Initiation of allergen immunotherapy within 6 months of screening.
研究组 & 干预措施
Investigational drug - Dose 1
Experimental
干预措施: ACT-129968 (Drug)
Investigational drug - Dose 2
Experimental
干预措施: ACT-129968 (Drug)
Investigational drug - Dose 3
Experimental
干预措施: ACT-129968 (Drug)
Investigational Drug - Dose 4
Experimental
干预措施: ACT-129968 (Drug)
Active Matching Reference
Other
干预措施: Cetirizine (Drug)
Matching Placebo
Placebo Comparator
干预措施: ACT-129968 (Drug)
Matching Placebo
Placebo Comparator
干预措施: Cetirizine (Drug)
Matching Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
时间窗: Baseline to week 2
次要结局
- To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.(Baseline to week 2)
研究者
研究点 (7)
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