A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
研究概览
简要总结
This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is a postmenopausal female 40 to 75 years of age
- •Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2
- •Patient has a documented history of overactive bladder for at least 6 months prior to screening
排除标准
- •Patient has stress or mixed incontinence
- •Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
- •Patient has a history of stroke, seizures, or major neurological disorders
- •Patient has a history of fecal incontinence
- •Patient has a history of continual urine leakage
- •Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start
- •Patient received bladder training of electrostimulation within 2 weeks of study start
- •Patient requires a catheter
- •Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
- •Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
- •Patient has been on hormone replacement therapy for less than 12 weeks at study start
- •Patient must take medication for arrhythmia
- •Patient consumes more than 2 alcoholic beverages per day
- •Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine)
- •Patient has multiple and/or severe allergies to foods and drugs
- •Patient regularly uses any illegal drugs
研究组 & 干预措施
1
Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
干预措施: tolterodine tartrate (Drug)
2
Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
干预措施: tolterodine tartrate (Drug)
3
Part II, Sequence 1: study drug crossing over to placebo
干预措施: tolterodine tartrate (Drug)
4
Part II, Sequence 2: placebo crossing over to study drug
干预措施: tolterodine tartrate (Drug)
结局指标
主要结局
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
时间窗: 4 hours post dose 7
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
次要结局
- Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo(4 hours post dose 1)