NCT02715024已完成4 期
An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms
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
- 52
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
研究概览
简要总结
The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
- •I-PSS(S) score of ≥ 12
- •Maximum flow rate (Qmax) of 4 to15 mL/sec
- •Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
- •Benign digital rectal examination (DRE) result
排除标准
- •Clinically significant outflow obstruction
- •Significant post void residue volume (PVR >100ml)
- •Prostate specific antigen (PSA) ≥10 ng/mL
- •Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
- •Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
- •Patient with a neurological cause for abnormal detrusor activity
- •Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
- •Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- •Patients with any other complication which may cause voiding dysfunction
- •Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
- •Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
- •Use of drugs to treat incontinence currently
- •Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
- •Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- •Patients had taken any investigational drug in the previous 3 months prior to this study
研究组 & 干预措施
Tamsulosin alone
Experimental
干预措施: Tamsulosin (Drug)
Tamsulosin + solifenacin
Experimental
干预措施: Tamsulosin (Drug)
Tamsulosin + solifenacin
Experimental
干预措施: Solifenacin (Drug)
结局指标
主要结局
Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
时间窗: Baseline and end of treatment (up to 12 weeks)
次要结局
- Safety as assessed by laboratory parameters(Up to 12 weeks)
- Change in mean number of micturitions per 24 hours from baseline to the end of treatment(Baseline and end of treatment (up to 12 weeks))
- Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment(Baseline and end of treatment (up to 12 weeks))
- Safety as assessed by adverse events(Up to 12 weeks)
- Change in mean number of urgency episode per 24 hours from baseline to the end of treatment(Baseline and end of treatment (up to 12 weeks))
- Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment(Baseline and end of treatment (up to 12 weeks))
- Safety as assessed by postvoid residual volume (PVR)(Up to 12 weeks)
- Safety as assessed by vital signs(Up to 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPHLower Urinary Tract SymptomsProstatic HyperplasiaNCT00510406Astellas Pharma Inc919
已完成
3 期
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract SymptomsLower Urinary Tract SymptomsBenign Prostatic HyperplasiaNCT01018511Astellas Pharma Europe B.V.1,334
Unknown
4 期
Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral StonesUreteral CalculiNCT01167062Chiang Mai University120
已完成
2 期
Tamsulosin and preventing of postoperative urinary retentioIRCT2012111411469N1Chancellor for research, Hamadan University of Medical Sciences67
已完成
1 期
CKD-397 Drug-drug Interaction Study (A)HealthyNCT02247518Chong Kun Dang Pharmaceutical16