NCT00972738已完成3 期
A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study
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
- 1,214
- 主要终点
- Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
研究概览
简要总结
This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a documented history of season allergic rhinitis symptoms that flare up during the study season
- •Patient is a nonsmoker
- •Patient is in good general health
排除标准
- •Patient is hospitalized
- •Patient is a woman who is <8 weeks postpartum or is breast-feeding
- •Patient has had major surgery in the past 4 weeks
- •Patient intends to move or vacation away during the study
- •Patient is a current or past abuser of alcohol or illicit drugs
研究组 & 干预措施
1
Experimental
montelukast
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
时间窗: Baseline and over the 2-week treatment period
Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
次要结局
- Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period(End of the 2-week treatment period)
- Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period(End of the 2-week treatment period)
- Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period(Baseline and over the 2-week treatment period)
- Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period(Baseline and over the 2-week treatment period)
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period(Baseline and at the end of 2-week treatment period)
研究者
相似试验
已完成
3 期
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)Seasonal Allergic RhinitisNCT00968149Organon and Co413
已完成
4 期
Linear Growth Study (0476-097)(COMPLETED)AsthmaNCT00395408Organon and Co360
已完成
3 期
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)Seasonal Allergic RhinitisNCT00963469Organon and Co1,079
已完成
4 期
Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)Asthma, BronchialNCT00092092Organon and Co71
已完成
3 期
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)Perennial Allergic RhinitisNCT00974571Organon and Co1,365