NCT00845338终止2 期
A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 7
- 主要终点
- Change from baseline in volume at first detrusor contraction as determined by urodynamics
研究概览
简要总结
The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with multiple sclerosis for at least 6 months
- •Neurogenic detrusor overactivity without DSD
- •Symptoms of OAB
- •Patients capable of completing the bladder diary
- •Patients capable of independent toileting
- •Patients able to swallow the study medication in accordance to the protocol
- •Body Mass Index >/= 18,8 kg/qm and </= 35,0 kg/qm
- •documented, dated, written informed consent
排除标准
- •Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
- •Participation in a bladder-training program
- •Low compliance bladder (Compliance <20 mL/cm H2O)
- •DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
- •Indwelling catheter or intermittent self-catheterization
- •Patience with post-void residual (PVR) urinary volume > 200 mL at baseline
- •Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
- •Clinically predominant and bothersome stress urinary incontinence
- •Neurological diseases other than multiple sclerosis affecting urinary bladder function
- •Any urogenital surgery within 12 month prior to Visit 1
- •17 Additional Exclusion Criteria
研究组 & 干预措施
Arm 1
Experimental
干预措施: Darifenacin (BAY79-4998) (Drug)
结局指标
主要结局
Change from baseline in volume at first detrusor contraction as determined by urodynamics
时间窗: At week 4
次要结局
- Compliance(At week 4)
- Detrusor pressure at first contraction(At week 4)
- Volume at first detectable leakage(At week 4)
- Volume at 10/20/30/40 cm H2O(At week 4)
- Maximum cystometric bladder capacity(At week 4)
- 7-day micturition diary: Micturitions(At days 0, 14, 28)
- 7-day micturition diary: Urgency episodes(At days 0, 14, 28)
- 7-day micturition diary: Urge urinary incontinence episodes(At days 0, 14, 28)
研究者
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