A Multi-center, Prospective, Open-label, Single-arm, 12-weeks, Phase IV Trial to Evaluate the Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Incidence of nocturia
研究概览
简要总结
The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia.
详细描述
This study is designed as a multi-center, prospective, open-label and single-arm study. Subjects who are willing to provide written informed consent will be enrolled after screening for eligibility criteria. The subjects will be administered with investigational product for 12 weeks and visit as outpatients for evaluation of safety and efficacy at baseline (visit 2) and 4 weeks (visit 3) and 12 weeks (visit 4) after baseline.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males of at least 50 years of age, with current diagnosis of benign prostatic hyperplasia
- •Symptoms of nocturia evidenced by ≥2 episodes per night in average according to 3-day voiding diary
- •More than total of 8 points on IPSS and 3 points on QoL
- •Able to provide written informed consent and to comply with all study procedures
排除标准
- •PSA level > 10 ng/㎖ (except patients who had 4 ng/㎖ < PSA level ≤ 10 ng/㎖ 6 months prior to screening and identified as negative from biopsy)
- •Symptoms of postural hypotension
- •Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
- •Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
- •Severe cardiac disorders or development or diagnosis of vascular disorder (unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, coronary artery bypass graft, etc) 6 months prior to enrollment
- •Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
- •Patients with bladder cancer, cystolith or urethral stricture
- •Patients with neurogenic bladder
- •History of acute urinary retention
- •Indwelling catheter or self intermittent catheterization
- •Patients with pyuria 1 month prior to screening
- •History of prostatic cancer
- •History of prostatic surgery
- •Patients with uncontrolled chronic disease
- •Alcoholism or sustained drug dependent abuse 1 year prior to screening
- •Hypersensitivity to α1A-receptor blockers
- •Administration of following drugs within according periods prior to screening - 2 weeks: Antimuscarinic agents (Tolterodine, Trospium, Solifenacin, Fesoterodine, Propiverine, Oxybutynin, Flavoxate, etc), Anticholinesterase agents (Neostigmine methylsulfate, etc), Cholinergic agonists (Bethanechol Cl, etc), Benign prostatic hyperplasia agents (Tamsulosin HCl, Prazosin HCl, Terazosin HCl, Doxazosin mesylate, Silodosin, Naftopidil, etc), Tricyclic antidepressants (Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Quinupramine, etc), 6 months: 5-α-Reductase Inhibitors (Finasteride, Dutasteride)
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
研究组 & 干预措施
Silodosin
Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
干预措施: Silodosin (Drug)
Silodosin
Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
干预措施: Laboratory tests (Other)
Silodosin
Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
干预措施: 3-days voiding diary (Other)
Silodosin
Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
干预措施: 12 weeks (Other)
结局指标
主要结局
Incidence of nocturia
时间窗: 12 weeks
Descriptive statistics for incidence of nocturia will be provided for each visit. Paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.
次要结局
- Mean change in International Prostate Symptom Score(IPSS) from baseline(12 weeks)
- Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline(12 weeks)
- Mean change in Quality of Life(QoL) scores from baseline(12 weeks)
- Mean change in Overactive Bladder Symptom Score(OABSS) from baseline(12 weeks)
- Ratio of subjects with ≥ 25% decrease in IPSS(12 weeks)
- Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline(12 weeks)
- Mean change in Question 1 (postvoiding symptoms) of IPSS from baseline(12 weeks)
- Mean change in Questions 2, 4 and 7 (storage symptoms) from baseline(12 weeks)
- Ratio of subjects with ≥ 25% decrease in incidence of nocturia(12 weeks)