EUCTR2015-002277-38-IT进行中（未招募）1 期
rodynamic evaluation by pressure flow urodynamic study of the new a1A-adrenoceptor antagonist silodosin 8 mg qd in patients with benign prostatic obstruction. Explorative, single-arm, phase IV clinical study. - Urodynamic effects of silodosin
RECORDATI S.P.A.0 个研究点目标入组 30 人开始时间: 2017年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Male subjects aged 50 years or older;
- •Patients waiting to undergo surgical intervention for LUTS/BPH;
- •No pharmacological treatment for LUTS/BPH in the last 4 weeks;
- •Presence of moderate-severe LUTS, as assessed by an IPSS total score ? 13 at Visit 1 (Screening);
- •Quality of life affected by LUTS, as assessed by a IPSS-QoL score = 3 at Visit 1 (Screening);
- •Prostate volume of ? 30 ml, assessed by suprapubic ultrasound;
- •Maximum urine flow rate (Qmax) = 15 mL/sec., with a minimum voided volume of ? 125 mL;
- •Presence of obstruction in urodynamic study performed at Visit 2 (Baseline), according to Inetrnational Continence Society (ICS) nomogram, based on the Bladder Outlet Obstruction Index (BOOI) > 40;
- •Agree not to use any other approved or experimental BPH or overactive bladder medication anytime during the study;
- •Able to comply with protocol procedures;
- •Written informed consent obtained before beginning any investigational procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Hypersensitivity to the active substance or to any of the excipients;
- •Absolute indication for surgery therapy (such as recurrent or refractory urinary retention, overflow incontinence, recurrent UTIs, bladder stones or diverticula, treatment resistant macroscopic haematuria due to BPH/BPE, or dilatation of the upper urinary tract due to BPO, with or without renal insufficiency) for which any delay in the intervention is not recommended;
- •Neurological causes of detrusor overactivity (e.g. multiple sclerosis, Parkinson’s disease, diabetic neurophathy);
- •Presence of active urinary tract infections;
- •Presence or history of bladder calculi;
- •Presence of prostate cancer. Subjects with a PSA > 10.0 ng/mL will be excluded. Subjects with a PSA between 4.0 and 10.0 should have prostate cancer ruled out to the satisfaction of the clinical Investigator with appropriate documentation of the physician’s assessment;
- •Post-void residual urine volume > 300 mL, assessed by suprapubic ultrasound;
- •Clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, significant ventricular arrhythmias, heart failure (NYHA classes III-IV), stroke, transient ischemic attack;
- •Renal impairment (serum creatinine > 2.0 mg/dL);
- •Hepatic impairment (GGT, AST or ALT > 3xULN);
- •Patients for whom cataract surgery is scheduled;
- •History of orthostatic hypotension or syncope;
- •Participation in an investigational drug study within 30 days prior to the start of the study;
- •Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or which prevents optimal participation in achieving the objectives of the study;
- •Prohibited concomitant medications:
- •a-adrenoceptor antagonists, 5-?-reductase inhibitors such as dutasteride and finasteride, natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serulata/repens), tadalafil 5 mg daily, anticholinergic agents, antidepressants, anti-anxiety agents during study participation. Note: occasional use of PDE-5 inhibitors for erectile dysfunction is allowed but not within 48 hours of any study visit.
- •Concomitant use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible PK interaction).
研究者
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