jRCT2080222549未知3 期
A double-blind, placebo-control, randomized phase III study to evaluate the efficacy and safety of TAC-202 in patients with perennial allergic rhinitis
试验速览
- 阶段
- 3 期
- 入组人数
- 750
- 主要终点
- Mean change in total nasal symptom scores (TNSS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Double-blind, randomized, placebo-controlled, parallel-group, multicenter
入排标准
- 年龄范围
- 18age old over 至 74age old under(—)
- 性别
- All
入选标准
- •Subjects who have been diagnosed with perennial allergic rhinitis and who have had related symptoms for 2 years or longer.
- •Subjects who showed positive in nasal provocation test with house dust disc.
排除标准
- •Subjects who previously developed anaphylaxis to antihistamine drugs, fexofenadine or ingredients of the investigational drug.
- •Subjects with any of the following complications that may hinder efficacy evaluation
- •Vasomotor rhinitis, - Eosinophilic rhinitis, - Drug-induced rhinitis,
- •Viral conjunctivitis, - Otitis media,
- •Others (acute/chronic rhinitis, hypertrophic rhinitis, sinusitis, nasal polyps, repetitive nasal hemorrhage, treatment-requiring nasal septal deviation, etc.)
结局指标
主要结局
Mean change in total nasal symptom scores (TNSS)
Scores for rhinorrhea, sneezing, nasal congestion and nasal itching
Symptoms score by subjects
Using the patient's diary card
次要结局
- QOL
- Degree of satisfaction with treatment
- Degree of improvement
研究者
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