Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 20
- 主要终点
- Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
研究概览
简要总结
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presents symptoms of overactive bladder
- •Patient has age associated memory impairment
- •No acute or unstable medical conditions
排除标准
- •History of alcohol or substance abuse within 1 year prior to study
- •Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
- •Has known bleeding disorder (hemophilia)
- •Previous abdominal bypass surgery for obesity
研究组 & 干预措施
Sanctura XR®
Sanctura XR® (trospium chloride), 60mg once daily for 10 days
干预措施: trospium chloride (Drug)
Oxybutynin IR
Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days
干预措施: oxybutynin IR (Drug)
Oxybutynin IR placebo
Oxybutynin IR placebo three times daily for 2 days
干预措施: oxybutynin IR placebo (Drug)
结局指标
主要结局
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
时间窗: Day 2 Post-Dose
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
时间窗: Day 10 Post-Dose
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.
次要结局
- Plasma Levels of Sanctura XR® at Day 10 Post-dose(Day 10 Post-Dose)
- Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10(Baseline, 10 Days)
- Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose(Day 2 Post-Dose)
- Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10(Baseline, 10 Days)
- Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10(Baseline, 10 Days)
- Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10(Baseline, 10 Days)