跳至主要内容
临床试验/NCT00845338
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

Bayer0 个研究点目标入组 7 人开始时间: 2007年2月最近更新:
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

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

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

相似试验