JPRN-jRCT2080222929已完成3 期
A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 438
研究概览
简要总结
S-524101 sublingual tablets were administered to pediatric patients with perennial allergic rhinitis due to house dust mites at the maintenance dose of 300 IR for 52 weeks. Sublingual administration of S-524101 statistically significantly improved the symptoms of house dust mite-induced allergic rhinitis compared with placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 <= 16age old（—）
- 性别
- All
入选标准
- •Patients who have a history of perennial allergic rhinitis symptom for two years or more.
- •Patients with a score of 3 or higher on the quantitative analysis of IgE antibody (CAP-RAST) specific to D. pteronyssinus and/or D. farinae antigens.
- •Patients who are positive for nasal provocation test by using allergen disc for house dust.
排除标准
- •Patients with allergic rhinitis, conjunctivitis, asthma, or other symptoms due to antigens other than HDM, which could confound accurate symptom assessment during the primary evaluation period.
研究者
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