NCT01900054已完成3 期
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
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
- 58
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events and Adverse Drug Reactions
研究概览
简要总结
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
详细描述
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 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 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
Experimental
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)
结局指标
主要结局
Number of Patients With Adverse Events and Adverse Drug Reactions
时间窗: Up to Week 12
次要结局
- Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)(Week 12 or suspension)
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.(Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）)
- Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)(baseline, Week2, Week4, Week6, Week8, Week10 and Week 12)
- Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)(Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12)
- Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis(baseline, Week2, Week4, Week6, Week8, Week10 and Week 12)
- Influence of Activities in Daily Life(Study, Outing, Sleeping)(Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12)
研究者
研究点 (1)
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