NCT01051336已完成1 期
Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)
TARIS Biomedical, Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal
研究概览
简要总结
The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers, 18 to 55 years of age
- •Body weight >100 lbs and BMI (body mass index) within the range 18-30 kg/m2
- •A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)
排除标准
- •Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
- •History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
- •History of kidney stone formation
- •Chronic or recurring bacterial or viral infections of the urogenital system
结局指标
主要结局
Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal
时间窗: 14 days
次要结局
- Subject reported symptoms(14 days)
- Routine and microscopic urinalysis(14 days)
- Urine culture(14 days)
研究者
研究点 (1)
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