A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 638
- 主要终点
- Change from baseline in mean number of urgency episodes per 24 hours
研究概览
简要总结
To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks
详细描述
Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
- •Patients with urgency episodes and frequent micturitions
- •Written informed consent has been obtained
- •Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL
排除标准
- •Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
- •Patients with obvious stress urinary incontinence
- •Patients with complications or who have a past history of a bladder tumor
- •Patients with urethral stricture or bladder neck stenosis
- •Patients with a history of surgery causing damage to the pelvic plexus
- •Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
- •Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder
研究组 & 干预措施
1. Tamsulosin alone
干预措施: Tamsulosin hydrochloride (Drug)
2. Tamsulosin + solifenacin (low dose)
干预措施: Tamsulosin hydrochloride (Drug)
2. Tamsulosin + solifenacin (low dose)
干预措施: Solifenacin succinate (Drug)
3. Tamsulosin + solifenacin (high dose)
干预措施: Tamsulosin hydrochloride (Drug)
3. Tamsulosin + solifenacin (high dose)
干预措施: Solifenacin succinate (Drug)
结局指标
主要结局
Change from baseline in mean number of urgency episodes per 24 hours
时间窗: at 4, 8, 12 week
次要结局
- Mean number of micturitions per 24 hrs(at 4, 8, 12 week)
- Mean number of incontinence episodes per 24 hours(at 4, 8, 12 week)
- Mean number of micturitions per night(at 4, 8, 12 week)
- Adverse Events, Laboratory Tests(end of study)