The Efficacy and Safety of Qianweitai (Silodosin Capsule) Compared to Tamsulosin in the Treatment of Benign Prostaic Hyperplasia (BPH) -A Multicenter, Prospecive, Randomized, Investigator-Blind, Positive-Controlled Study
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
- 6
- 主要终点
- International Prostate Symptom Score（IPSS）
研究概览
简要总结
The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are:
- Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？
- Dose QWT have other advantages in the improvement of LUTS?
Participants will:
- Orally take QWT twice daily or tamsulosin once daily for 12 weeks.
- Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.
详细描述
This trial is designed as two stages: screening period, treatment and follow-up period.
Screening period (days -28 to 0): After signing the informed consent form, the subjects entered into the screening period, and made a 24-hour urination diary and screening examination.
Treatment and Follow-up period: eligible patients were randomly assigned to 2 groups according to 1: 1 and received Tamsulosin or Silodosin or for 12 weeks. During the treatment period, the subjects' diaries were recorded according to the requirements of the scheme, and they were followed up at 1 week (7±2 days), 2 weeks (14±3), 4 weeks (28±5 days), 8 weeks (56±7 days) and 12 weeks (84±10 days). During the visit, relevant scale scores and laboratory examinations were performed, and the occurrence of adverse events during the follow-up was recorded to evaluate the safety.
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
- Double (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
Qianweitai
Patients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner).
干预措施: Silodosin (Drug)
Tamsulosin
Patients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily).
干预措施: Tamsolusin (Drug)
结局指标
主要结局
International Prostate Symptom Score（IPSS）
时间窗: week 12
Changes of IPSS scores at the 12th week of treatment compared with baseline scores.
次要结局
- International Prostate Symptom Score（IPSS） total score(1, 2, 4 and 8 weeks)
- IPSS storage subscore(1, 2, 4 and 8 weeks)
- IPSS total score severity(week 12)
- Quality of life (QoL) score(4, 8 and 12 weeks)
- IPSS voiding subscore(1, 2, 4 and 8 weeks)
- Maximum urinary flow rate (Qmax)(week 12)
- Residual urine volume (PVR)(week 12)
- Prostate specific antigen (PSA)(week 12)
- Prostate volume (PV)(week 12)
- Responder rate(week 12)
- Proportion of patients with BPH clinical progression(week 12)