A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure
研究概览
简要总结
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight: ≥ 25 kg
- •Height: ≥ 125 cm
- •Able to record symptoms in a diary
- •Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]
- •Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay
排除标准
- •Has nasal findings that would interfere with evaluating nasal congestion symptoms
- •Past or present medical history of bronchial asthma
- •Medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by JC pollen exposure
研究组 & 干预措施
Placebo/Montelukast
Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
干预措施: Montelukast (Drug)
Montelukast/Placebo
Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
干预措施: Montelukast (Drug)
Montelukast/Placebo
Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
干预措施: Placebo (Drug)
Placebo/Montelukast
Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure
时间窗: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
Percentage of Participants Who Experience at Least One Adverse Event
时间窗: Up to 5 weeks
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.
次要结局
- Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure(Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period)
- Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room(Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period)
- Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure(Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period)
- Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room(Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period)
- Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure(Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period)
- Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure(Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period)
- Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room(Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period)
- Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room(Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period)
- Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room(Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period)