NCT01228370已完成4 期
A 12-week, Open-label, Multi-center Study to Evaluate the Clinical Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
JW Pharmaceutical6 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 6
- 主要终点
- I-PSS score change after treatment
研究概览
简要总结
Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors, α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with or without neurogenic bladder.
α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in patients with neurogenic bladder.
Based on these turnouts, we designed this clinical study to evaluate the clinical effect and safety of silodosin on voiding dysfunction associated with neurogenic bladder.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is 20 years old or over
- •Patient who is diagnosed with neurogenic bladder through urodynamic test, having urinary disorder symptoms
- •In case, patient has been taking concomitant drugs allowed for the study, only if the doses have been stable within 8 weeks from the screening visit
- •Patient who has a I-PSS score of 8 or over
- •Patient who has a QoL score of 3 or over
- •Patient who has a Qmax of below 15 mL/sec
- •Patient who has a PSA<4.0 ng/mL or has PSA>4.0 ng/mL with no opinion of prostate cancer from biopsy
- •Patient who is willing to take the investigational product in accordance with the protocol
- •Patient who is able to fill out questionnaire and understand requirements of the study including informed consent
- •Patient voluntarily decides to participate and signs the written consent form.
排除标准
- •Patient who hs urinate at all on his/her own.
- •Patient who has a history of bladder surgery
- •Patient who has detrusor areflexia or acontractile bladder diagnosed by urodynamic test
- •Patient who has a postvoid residual urine volume(PRV) of 300 mL or greater, or has a PRV of 50% or over of the maximum bladder capacity
- •Patient who has a prostate volume of 30 mL or greater resulted from a severe benign prostatic hyperplasia(BPH) (only in case of male)
- •Patient who has urethral stricture
- •Patient who has symptomatic urinary tract infection(UTI) before screening visit
- •Patient who has a gross hematuria(except idiopathic hematuria)
- •Patient who conducts Clean Intermittent Catheterization(CIC)
- •Patient who has been taking α-blocker other than silodosin or α-agonist within 8 weeks from screening visit
- •Patient who has a Botulinum toxin injection for bladder problems within at least 1 year from screening visit
- •Patient who has severe hapatic disorders(hepatic insufficiency, cirrhosis, jaundice, hepatoma)or has a total bilirubin of 2.5 mg/dL or higher or has AST/ALT 2.5 times higher than the normal upper limit
- •Patient who has a renal impairment with a serum creatinine 2.0 mg/dL or higher
- •Patient who has experienced severe arrhythmia, cardiac failure, myocardiac infarction, unstable angina, cerebral infarction within 6 months from screening visit
- •Patient who has orthostatic hypotention before screening visit
- •Patient who has a demanding chronic disease
- •Patient who has an allergy to drugs
- •Patient who is prohibited from taking silodosin
- •Patient who has to take drugs prohibited from the study during the clinical study
- •Patient who is pregnant or plans to be pregnant or is breastfeeding or is not practicing contraception using medically acceptable contracenption
- •Patient who has experienced any other clinical study within 4 weeks from screening visit
- •Patient who is excluded from medical dicisions made by the investigators
研究组 & 干预措施
Silodosin
Experimental
Silodosin 8mg once a day for 12 weeks
干预措施: silodosin (Drug)
结局指标
主要结局
I-PSS score change after treatment
时间窗: 12 weeks
次要结局
- Change in Qmax after treatment(12 weeks)
- Change in Postvoid Residual urine Volume(PRV) after treatment(12 weeks)
- Change in I-PSS Quality of Life after treatment(12 weeks)
研究者
研究点 (6)
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