A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 主要终点
- Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
研究概览
简要总结
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
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 (Participant, Care Provider, Investigator)
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
- •Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
- •BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
- •Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also)
- •Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.
排除标准
- •History of urinary retention in preceding 12 months
- •Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months.
- •Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
- •Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
- •Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1
研究组 & 干预措施
Placebo
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
干预措施: Placebo to solifenacin (Drug)
Placebo
Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
干预措施: Placebo to tamsulosin (Drug)
6 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
干预措施: solifenacin succinate (Drug)
6 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
干预措施: tamsulosin hydrochloride (Drug)
9 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
干预措施: solifenacin succinate (Drug)
9 mg Solifenacin + 0.4 mg Tamsulosin
Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
干预措施: tamsulosin hydrochloride (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
时间窗: Baseline and Week 12
The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
时间窗: Baseline and Week 12
Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.
次要结局
- Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests(From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).)
- Change From Baseline in IPSS Voiding Score(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in Patient Perception of Bladder Condition (PPBC)(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in International Prostate Symptoms Score (IPSS)(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in Number of Urgency Episodes Per 24 Hours(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in Post Void Residual Volume (PVR)(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)(Baseline and Week 12)
- Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score(Baseline and Weeks 4, 8 and 12)
- Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score(Baseline and Weeks 4, 8 and 12)
- Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)(Baseline and Week 12)
- Change From Baseline in Number of Incontinence Episodes Per 24 Hours(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in IPSS Storage Score(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score(Baseline and Weeks 4, 8 and 12)
- Change From Baseline in Number of Micturitions Per 24 Hours(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in Volume Voided Per Micturition(Baseline and Weeks 2, 4, 8 and 12)
- Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score(Baseline and Weeks 4, 8 and 12)