NCT05551221已完成4 期
The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study
Xintian Pharmaceutical8 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年9月21日最近更新:
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
- 110
- 试验地点
- 8
- 主要终点
- International Prostate Symptom Score（IPSS）
研究概览
简要总结
Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules.
Study design: A multicenter, prospective, randomized, investigator-blind, active controlled clinical study.
Interventions:
Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
详细描述
Sample size: 108
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
- •Has an IPSS score ≥ 8 points at Screening and Baseline.
- •Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
- •Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
- •Subjects who can read, understand, and complete the research questionnaire.
- •Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.
排除标准
- •Subjects with prostate cancer or other malignant tumors.
- •Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
- •Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- •Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.
- •Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
- •Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization.
- •Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
- •Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
- •Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
- •Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
- •There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) > 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L).
- •Subjects who are allergic to the drugs or ingredients used in the test definitely.
- •Any otherSubjects in the opinion of researchers is not suitable for inclusion.
研究组 & 干预措施
Tamsulosin Hydrochloride Capsules
Active Comparator
Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily)
干预措施: Tamsulosin (Drug)
Silodosin Capsules
Experimental
Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner)
干预措施: Silodosin Capsules (Drug)
结局指标
主要结局
International Prostate Symptom Score（IPSS）
时间窗: 12 week
Changes of IPSS scores at the 12th week of treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
次要结局
- IPSS total score severity(12 week)
- Patient response rate(12 weeks)
- IPSS Stimulus score(12 weeks)
- IPSS obstruction score(12 weeks)
- International Prostate Symptom Score（IPSS） total score(1, 2, 4 and 8 weeks)
- Quality of life (QoL) score(4, 8 and 12 weeks)
- Maximum urinary flow rate (Qmax)(12 weeks)
- Residual urine volume (PVR)(12 weeks)
研究者
研究点 (8)
Loading locations...
相似试验
Unknown
2 期
Safety and Efficacy of Silodosin in the Treatment of Premature EjaculationPremature EjaculationNCT02581826Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation40
尚未招募
4 期
A study to compare safety and efficacy of silodosin versus mirabegron in patients with lower uretericstoneCTRI/2023/08/057036Dr Rajendera Prasad Government Medical College, Kangra at Tanda, Himachal Pradesh India
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 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: 8.1Level: LLTClassification code 10004446EUCTR2005-005665-11-FIRecordati S.p.A1,400
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: 8.1Level: LLTClassification code 10004446EUCTR2005-005665-11-ESRecordati S.p.A1,400