NCT00578331已完成3 期
Safety Study of Olopatadine Nasal Spray
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 890
- 试验地点
- 1
- 主要终点
- Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
研究概览
简要总结
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
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
- •Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older
排除标准
- •Age 11 years and younger
研究组 & 干预措施
Olopatadine 0.6% Nasal Spray
Experimental
2 sprays each nostril twice daily
干预措施: Olopatadine 0.6% nasal spray (Drug)
Placebo Nasal Spray
Placebo Comparator
2 sprays each nostril twice daily
干预措施: Placebo Nasal Spray (Drug)
结局指标
主要结局
Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
时间窗: day 30
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
次要结局
- Average Number of Days of Rescue Medication Taken(Month 1 through Month 12)
研究者
研究点 (1)
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