A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 473
- 试验地点
- 2
- 主要终点
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
研究概览
简要总结
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
详细描述
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary endpoint; and to investigate safety of TAU-284.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 7 and 15 years
- •Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
- •Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.
排除标准
- •Patients with vasomotor rhinitis or eosinophilic rhinitis
- •Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
- •Patients with a history of any of the nasal surgical procedures
- •Patients who have a positive result for pollen antigens which are dispersed during the study period
- •Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats.
- •Patients with current or previous history of drug allergy
- •Patients who concurrently have renal function abnormalities that may cause safety problems etc.
研究组 & 干预措施
TAU-284
Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
干预措施: Bepotastine besilate (Drug)
Placebo
Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
时间窗: Baseline and Week 2
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).
次要结局
- Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)(baseline, Week1 and Week 2)
- Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)(baseline, Week1 and Week 2)
- Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis(Randomization, Week1 and Week 2)
- Adverse Events and Adverse Drug Reactions(Week 2)
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion](baseline, Week1 and Week 2)