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
- 490
- 试验地点
- 5
- 主要终点
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)
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 the dose response, safety, and plasma concentrations of TAU-284.
详细描述
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations 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 with a weight of at least 20 kg
- •Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
- •Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period
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
- •Patients with current or previous history of drug allergy
- •Patients who concurrently have renal function abnormalities that may cause safety problems
研究组 & 干预措施
TAU-284 Low
干预措施: TAU-284 (Drug)
TAU-284 High
干预措施: TAU-284 (Drug)
Placebo
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] (at Final Evaluation)
时间窗: Baseline and Week 2
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .
次要结局
- Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)(Week 2)
- Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)(Week 2)
- Change From Baseline in Severity Score(Week 2)
- Adverse Events and Adverse Drug Reactions(Week 2)
- Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)(Week 2)
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion](Week 2)