A Randomized Open Label Phase-II Control Trial to Evaluate the Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Assessment criteria Efficacy
研究概览
简要总结
To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms.
详细描述
I.Test drug
- Name: Silodosin 8mg/capsule
- Dosage form: capsule (Silodosin)
- Dose(s): 8mg
- Dosing schedule: Oral, once daily
- Mechanism of action: Silodosin blocks the α1A-adrenergic receptors in the prostate gland and urethra, causing smooth muscle relaxation. Since the intraurethral pressure of the urethra is reduced, urine can pass more easily and the urinary symptoms are relieved.
- Pharmacological category: α1A-adrenergic receptor blocker
II.The process of the experiment (brief describe) Eligible subjects will be randomized to a study medication according to the randomization schedule (a 1:1 randomization ratio). There are 2 groups in this study, with group A (treatment group, silodosin 8mg, once daily, 8-week duration) and group B (control group).
III. The primary endpoint is the rate of Foley removal. The secondary endpoints are the rate of urinary tract infection, residual urine amount and the rate of re-on Foley.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ≥ 20 years of age
- •Newly diagnosed of acute brain injury with Foley insertion with 5 days
排除标准
- •Subjects with already in use of α1A-adrenergic receptor blocker used
- •Subjects with urethral trauma
- •Subjects with a history of prostate, penile, testicular, bladder, or urethral cancer or has received pelvic radiation, systemic chemotherapy, or intravesical chemotherapy
- •Expected survival days for brain injury less than 28 days
- •Subjects with a history of renal dysfunction (elevated creatinine (>2.0 mg/dL))
- •Subjects with severe liver impairment (Child-Pugh score≧10)
- •Subjects with CYP3A4 inhibitors (ketoconazole、clarithromycin、itraconazole、ritonavir) used
- •Subjects with pregnancy
- •Subject who has been in an investigational drug study in the past 3 months
- •Subjects who is considered as ineligible for participation in this clinical study by the principle investigator or the co-investigator's judgement.
研究组 & 干预措施
Experiment group
- Subject ≥ 20 years of age
- Newly diagnosed of acute brain injury with Foley insertion with 5 days
干预措施: Silodosin 8 mg (Drug)
结局指标
主要结局
Assessment criteria Efficacy
时间窗: 56 day
Efficacy: the rate of Foley removal
Assessment criteria Safety
时间窗: 56 day
Silodosin-related adverse events
次要结局
- Assessment criteria Efficacy(56 day)