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临床试验/jRCT2080222549
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

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 750 人开始时间: 待定

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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