JPRN-jRCT2080222901已完成3 期
Phase III clinical trial of TO-203 - Evaluation of efficacy and safety in pediatric patients with HDM-induced allergic rhinitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 458
研究概览
简要总结
In pediatric subjects aged 5 to 17 years, the superiority of the TO-203 sublingual tablet 10,000 JAU to placebo was confirmed. It was considered that the TO-203 sublingual tablet 10,000 JAU has a favorable safety profile in pediatric subjects aged 5 to 17 years.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 <= 17age old（—）
- 性别
- All
入选标准
- •(1) Patients with HDM-specific IgE : class 3 or more.
- •(2) Patients with positive nasal provocation test.
- •(3) Patients with a history of prescription drug treatment for perennial allergic rhinitis.
- •(4) Patients with moderate or severe symptoms of HDM-induced allergic rhinitis.
排除标准
- •(1) Patients with class 5 or more in the specific-IgE antibody tests to any of the following: cedar, cypress, alder, Betula, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog dander, or cat dander.
- •(2) Patients with class 2 to 4 in the specific-IgE antibody tests to any of the following: cedar, cypress, alder, Betula, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog dander, or cat dander, and who have symptoms of allergic rhinitis due to these relevant antigen
- •(3) Patients with class 2 to 4 in the specific-IgE antibody tests to dog dander or cat dander, and who have no symptoms of allergic rhinitis, while being constantly exposed to these relevant animal (e.g., pet parenting at home)
研究者
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