EUCTR2014-004921-41-Outside-EU/EEA进行中（未招募）不适用
Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis - Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray
Corporation Schering-Plough K.K.0 个研究点目标入组 333 人开始时间: 2015年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 333
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1) Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, according to the classification of severity in the Practical Guideline for the Management of Allergic Rhinitis in Japan (partial revision, 2009) as well as a total score of at least 4 for nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), after the pretreatment observation period. As a rule, subjects should fulfill above criteria at the time of obtaining informed consent.
- •(2) Subjects confirmed to be allergic to non-seasonal environmental antigens based on the tests.
- •(3) Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
- •(4) Subjects whose parents/legal representatives can provide written informed consent.
- •(5) Subjects who can make entries in the nasal allergy diary or have a parent/legal representative who can make entries.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 333
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) judged by the investigator to require treatment at the time of registration
- •(2) Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
- •(3) Subjects with repeated epistaxis
- •(4) Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
- •(5) Subjects with a history of hypersensitivity to steroids and other components of the study drug
- •(6) Female subjects with positive pregnancy test (conducted only in subjects 7 years of age and older)
- •(7) Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
- •(8) Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the study period (at any time from the start of the observation
- •period to the end of treatment).
- •(9) Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
- •(10) Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
- •(11) Subjects who develop a disease affecting nasal symptoms (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis) in the 7 days before registration in the study.
- •(12) Subjects who have previously received MFNS.
- •(13) Subjects who have taken of an investigational drug within 120 days (4 months) before the day of informed consent.
- •(14) Subjects for whom the period of discontinuation of previous treatment before the start of study
研究者
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