NCT01259531已完成4 期
A 12-week, Open Label, Multi-center Study to Investigate the Efficacy and Safety of a α1A Adrenoceptor Selective Antagonist Silodosin on Urinary Disturbance Associated With Benign Prostatic Hyperplasia
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年12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
- 100
- 试验地点
- 1
- 主要终点
- Total International prostate symptom score(IPSS) score before and after treatment
研究概览
简要总结
This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).
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
- •Is at least 50 years old
- •Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher
- •Has a QoL score of 3 or higher
- •Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec
- •Has a PRV of below 100mL
- •Voluntarily decides to participate in this trial and sign with informed consent form
排除标准
- •Has been administered silodosin
- •Has been administered an α1A-adrenoceptor blocker within one month
- •Has been prescribed antiandrogens except 5α-reductase inhibitors within a year
- •Has had phytotherapy within 3 months
- •Has had prostatectomy
- •Has had intrapelvic radiation therapy
- •Has had transurethral microwave hyperthermia of transurethral needle ablation
- •Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI).
- •Is conducting self-catherterization
- •Has a renal impairment with a serum creatinine of 2.0mg/dL or greater
- •Has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or has a total bilirubin of 2.5mg/dl or higher or has AST/ALT 2.5 times higher than the normal (upper) level
- •Has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- •Has experienced allergy to α1 receptor blockers
- •Has orthostatic hypotension around the time of Screening Visit
- •Has participated in other clinical trials within 8 weeks prior to Screening Visit
- •Has a Prostate specific antigen(PSA) of higher 10ng/mL or has been diagnosed with tumor identified by a biopsy even though he has a PSA of lower 10ng/mL (Patient who has been administered 5α-reductase inhibitors for more than 3 months are presumed to have 2 times higher than their actual PSA levels)
- •Has been taking unstable dosing of 5α-reductase inhibitors like finasteride or dutasteride for the past 3 months or is expected to change the dosage during the trial.
研究组 & 干预措施
Silodosin
Experimental
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
干预措施: Silodosin (Drug)
结局指标
主要结局
Total International prostate symptom score(IPSS) score before and after treatment
时间窗: For 12 weeks
Assess the improvement of lower urinary tract symptoms with change in total IPSS score before and after treatment.
次要结局
- Quality of life(QoL) score before and after treatment(For 12 weeks)
- Maximal urinary flow rate(Qmax) before and after treatment(For 12 weeks)
- Voiding score of IPSS before and after treatment(For 12 weeks)
- Storage scores of IPSS before and after treatment(For 12 weeks)
- Post void residual urine volume(PVR) before and after treatment(For 12 weeks)
研究者
研究点 (1)
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