NCT01089751已完成4 期
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
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
- Allergan
- 入组人数
- 322
- 主要终点
- Percentage of Patients Continent (PPC)
研究概览
简要总结
This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
- •Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
- •Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).
排除标准
- •Predominant stress or insensate incontinence
- •History of neurogenic bladder
- •Two urinary tract infections in the last six months
- •Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
- •Donated >500mL blood in the 30 days prior to the screening visit
研究组 & 干预措施
Sanctura XR®
Experimental
Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
干预措施: trospium chloride (Drug)
Placebo
Placebo Comparator
Placebo once daily on an empty stomach for 14 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Patients Continent (PPC)
时间窗: Week 14
PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.
次要结局
- Change From Baseline in Continent Days Per Week (CDW)(Baseline, Week 14)
- Change From Baseline in Urgency-Related Toilet Voids(Baseline, Week 14)
- Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)(Baseline, Week 14)
- Change From Baseline in Nocturic Toilet Voids(Baseline, Week 14)
- Change From Baseline in Voided Volume(Baseline, Week 14)
- Change From Baseline in Urgency Severity(Baseline, Week 14)
- Change From Baseline in Urgency Urinary Incontinence (UUI)(Baseline, Week 14)
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