NCT00439192终止2 期
A Multicenter, Randomized, Double-Blind, Parallel Group, Phase II, Forced Dose Titration Study to Investigate the Efficacy and Safety of 400mg and 600mg ELB245 Given Once Daily for 12 Weeks (8 + 4 Weeks) Versus Placebo and Versus 4mg Tolterodine Given Once Daily in Patients With Incontinent Overactive Bladder (OAB)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- elbion AG
- 入组人数
- 275
- 试验地点
- 46
- 主要终点
- mean number of micturitions
研究概览
简要总结
This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo , when administered to patients with OAB and to compare the efficacy of escalating doses of ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients at least 18 years of age
- •Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms) for a minimum of one month prior to study entry
- •Ability to use a toilet independently and without difficulty
- •No treatment with any medication against OAB during the 4 weeks prior to study entry
- •Written informed consent
排除标准
- •Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control
- •Any local pathology, that might cause the bladder symptoms
- •Significant stress urinary incontinence or mixed stress/urgency incontinence
- •Any neurological disease affecting bladder function or muscle strength
- •Patient history of any lower urinary tract surgery or previous pelvic irradiation
- •Local administration of botulinum toxin within the last 9 months in the lower urinary tract
- •Start or change of a behavioral bladder training program
- •Post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction
- •Nocturial polyuria
- •History of liver disease and/or impaired liver function
- •Cholestasis
- •Chronic alcohol or drug abuse
- •Evidence of significantly impaired renal function (
- •Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria
- •Inflammatory bowel disease such as Crohn's disease, or ulcerative colitis
- •Uncontrolled narrow angle glaucoma
- •Chronic use of carbamazepine or paracetamol
- •Participation in any drug study in the preceding 3 months
- •Concomitant treatment with strong CYP3A4 inhibitors
- •History or evidence of relevant cardiovascular or cerebrovascular disorders
结局指标
主要结局
mean number of micturitions
次要结局
- OAB related measures
- urgency measures
- Quality of life
研究者
研究点 (46)
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