A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Spinal Cord Injury Subjects With Neurogenic Detrusor Overactivity (NDO)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs
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 neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TAR-302-5018
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)
结局指标
主要结局
Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs
时间窗: Safety will be assessed from the signing of the informed consent form through Study Day 49 (+ 7 days) for a total of up to 77 days.
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(Tolerability will be assessed during the 42-day indwelling period unless removed due to lack of tolerability in advance of the Day 42 scheduled removal.)
- Peak Plasma Concentration (Cmax)(Seven time-points across 49 days (Day 0 through Day 49).)
- Peak Urine Concentration (Cmax)(Seven time-points across 49 days (Day 0 through Day 49).)
- Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Filling Phase - Detrusor Pressure(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Filling Phase - Bladder Compliance(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Instillation Volume(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Vesical Pressure(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Peak Flow(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Mean Flow(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Detrusor Pressure(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Post Void Residual Volume(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Detrusor Pressure(Day 0, Day 14 (+/- 1 day), Day 42)
- Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Total Voided Volume(Day 0, Day 14 (+/- 1 day), Day 42)