NCT01757769已完成4 期
Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,036
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score)
研究概览
简要总结
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.
详细描述
The objective of the study is to confirm in a larger and less selected population ("real life conditions") the positive risk-benefit balance observed with silodosin in double-blind, randomised clinical trials.
The following aspects will be evaluated:
- the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire
- the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire
- the effects on Quality of Life (QoL) due to urinary symptoms
- the safety profile
- the adherence to therapy
- the patient satisfaction with treatment The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Benign Prostatic Hyperplasia (BPH) by the urologist;
- •Male subjects aged 60 years or older;
- •IPSS total score equal or more than 12 at Visit 1 (Screening) and 2 (Baseline);
- •Able to comply with protocol procedures;
- •Written informed consent obtained before beginning any investigational procedures.
排除标准
- •Hypersensitivity to the active substance or to any of the excipients;
- •Patients for whom cataract surgery is scheduled;
- •History of orthostatic hypotension or syncope;
- •Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula);
- •Severe hepatic impairment;
- •Concomitant use of other α-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serrulate/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline);
- •Concomitant use with potent cytochrome P450 3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible pharmacokinetic interaction);
- •Prostate cancer;
- •History of prostate or bladder neck surgery, including transurethral prostatectomy, TUNA, laser or other minimally invasive therapy;
- •Active urinary tract infection;
- •Acute or recurrent prostatitis (more than 3 times in the last year);
- •History of neurological disease that may affect bladder function;
- •Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, percutaneous transluminal coronary angioplasty, congestive heart failure class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
- •History or current evidence of drug or alcohol abuse within the last 12 months;
- •Participation in a study involving the administration of an investigational compound within the past 30 days;
- •Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.
研究组 & 干预措施
Silodosin
Experimental
Silodosin capsule 8 mg daily for 24 weeks
干预措施: Silodosin (Drug)
结局指标
主要结局
The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score)
时间窗: 6 months o treatment
次要结局
- Change from baseline in IPSS total score(4, 12, 24 weeks of treatment)
研究者
研究点 (1)
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进行中（未招募）
1 期
Evaluation Of The Efficacy And Safety Of Silodosin Vs. Tamsulosin And Placebo In The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia. Multicentre, Randomised, Double-Blind, Controlled Trial With An Optional Long-Term Open-Label Extension PhaseBenign prostatic hyperplasia (BPH) is a non malignant enlargement of the prostate due to cellular hyperplasia of both glandular and stromal elements. As the prostate increases in size it may exert pressure on the lumen of the prostatic urethra, resulting in a gradual obstruction to urine flow.MedDRA version: 8.1 Level: LLT Classification code 10004446EUCTR2005-005665-11-GBRecordati S.p.A1,400
进行中（未招募）
不适用
Evaluation Of The Efficacy And Safety Of Silodosin Vs. Tamsulosin And Placebo In The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia. Multicentre, Randomised, Double-Blind, Controlled Trial With An Optional Long-Term Open-Label Extension PhaseEUCTR2005-005665-11-FIRecordati S.p.A1,400