NCT02953366撤回3 期
Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens
EMS0 个研究点开始时间: 2019年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Consent of the patient;
- •Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
排除标准
- •Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
- •Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Participation in clinical trial in the year prior to this study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Patients who were in use of drugs that can interfere with evaluation;
- •Decongestants dependent patients or patients receiving allergen specific immunotherapy;
- •Patients on treatment with monoamine oxidase inhibitors (MAOIs).
研究组 & 干预措施
EMS Mometasone gel
Experimental
The patient should administer 1 spray in each nostril once daily.
干预措施: EMS Mometasone gel (Drug)
Mometasone spray nasal
Active Comparator
The patient should administer 1 spray in each nostril once daily.
干预措施: Mometasone spray nasal (Drug)
结局指标
主要结局
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.
时间窗: 28 days
次要结局
- Safety will be evaluated by the adverse events occurrences(28 days)
研究者
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