A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Subjects With Idiopathic Overactive Bladder (iOAB) and Urinary Incontinence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 12
- 主要终点
- Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1)
研究概览
简要总结
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with idiopathic overactive bladder and urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TAR-302-5018 (42-day Indwelling)
Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 42. TAR-302-5018 releases trospium gradually during the 42 day indwelling time.
干预措施: Trospium-Releasing Intravesical System (TAR-302-5018) (Drug)
TAR-302-5018 (84-day Indwelling)
Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 84. TAR-302-5018 releases trospium gradually during the 84 day indwelling time.
干预措施: Trospium-Releasing Intravesical System (TAR-302-5018) (Drug)
结局指标
主要结局
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1)
时间窗: Upon insertion, 42-day continuous exposure, and removal
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 2)
时间窗: Upon insertion, 84-day continuous exposure, and removal
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
次要结局
- Tolerability of TAR-302-5018 (Part 1)(Upon insertion, 42-day continuous exposure, and removal)
- Reduction in daily micturition episodes (Part 1)(From Day 0 to Day 56)
- Tolerability of TAR-302-5018 (Part 2)(Upon insertion, 84-day continuous exposure, and removal)
- Pharmacokinetic Analysis of Plasma and Urine (Part 1)(From Day 0 to Day 56)
- Reduction in incontinence over baseline (Part 2)(From Day 0 to Day 112)
- Pharmacokinetic Analysis of Plasma and Urine (Part 2)(From Day 0 to Day 112)
- Reduction in incontinence over baseline (Part 1)(From Day 0 to Day 84)
- Reduction in daily micturition episodes (Part 2)(From Day 0 to Day 112)
- Increase in voided volume per micturition (Part 1)(From Day 0 to Day 56)
- Increase in voided volume per micturition (Part 2)(From Day 0 to Day 112)