NCT02967731已完成1 期
An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Product related serious adverse events from baseline visit to 4 weeks post procedure
研究概览
简要总结
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CS.
- •Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study.
- •The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
- •The study subject agrees to comply with all study requirements
排除标准
- •Known history of intolerance to corticosteroids.
- •Oral-steroid dependent condition.
- •Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit.
- •Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system).
- •Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range.
- •Previous pituitary or adrenal surgery.
- •History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts.
- •Recent participation in another clinical trial within 1 month of screening visit.
- •Subjects currently participating in an investigational drug or device study.
研究组 & 干预措施
480 Mometasone Furoate Sinus Drug Depot
Experimental
480 Mometasone Furoate Sinus Drug Depot
干预措施: 480 Mometasone Furoate Sinus Drug Depot (Drug)
结局指标
主要结局
Product related serious adverse events from baseline visit to 4 weeks post procedure
时间窗: 4 weeks post procedure
次要结局
- Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment(Up to 24 weeks)
研究者
研究点 (4)
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