A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 539
- 主要终点
- Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score
研究概览
简要总结
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PE 10 mg
干预措施: Phenylephrine HCl (Drug)
PE 10 mg
干预措施: Placebo (Drug)
PE 10 mg
干预措施: Loratadine (Drug)
PE 20 mg
干预措施: Phenylephrine HCl (Drug)
PE 20 mg
干预措施: Placebo (Drug)
PE 20 mg
干预措施: Loratadine (Drug)
PE 30 mg
干预措施: Phenylephrine HCl (Drug)
PE 30 mg
干预措施: Placebo (Drug)
PE 30 mg
干预措施: Loratadine (Drug)
PE 40 mg
干预措施: Phenylephrine HCl (Drug)
PE 40 mg
干预措施: Placebo (Drug)
PE 40 mg
干预措施: Loratadine (Drug)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Loratadine (Drug)
结局指标
主要结局
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score
时间窗: Baseline, Day 7
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.
次要结局
- Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period(Baseline and Days 1, 2, 3, 4, 5, 6, and 7)
- Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7(Baseline, Day 7)
- Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period(Baseline and Day 2, 3, 4, 5, 6, and 7)
- Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period(Baseline and Days 2, 3, 4, 5, 6, and 7)
- Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period(Baseline and Days 1, 2, 3, 4, 5, 6, and 7)
- Time to Maximal Effect(Baseline up to Day 7)
- Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period(Baseline and Days 1, 2, 3, 4, 5, 6, and 7)