EUCTR2012-000957-30-PT进行中（未招募）不适用
BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis
Allergan Ltd.0 个研究点目标入组 184 人开始时间: 2012年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) patient has multiple sclerosis, determined by documented patient history
- •- patient’s MS is clinically stable for = 3 months prior to screening, in the investigator’s opinion
- •- patient has an Expanded Disability Status Scale (EDSS) score of = 6.5
- •2) patient has NDO for a period of at least 3 months prior to screening, determined by documented patient history
- •- the presence of an involuntary detrusor contraction (IDC) must also be demonstrated during the urodynamic assessment in the screening period or day 1 (prior to randomization)
- •3) patient has not been adequately managed with one or more anticholinergics for their urinary incontinence, in the opinion of the investigator. Not adequately managed is defined as meeting one of the following:
- •- an inadequate response after at least a 4-week period of anticholinergic therapy on an optimized dose(s), ie, the patient was still incontinent despite anticholinergic therapy
- •- limiting side effects after at least a 2-week period of anticholinergic therapy on an optimized
- •4) for patients taking anticholinergic medication for their NDO at study entry, dose is stable and patient is willing to maintain the same dose during study participation
- •5) for patients not taking anticholinergics for their NDO at study entry, anticholinergics must have been discontinued at least 7 days prior to any screening procedures and anticholinergic treatment must not be commenced during the study
- •6) patient experiences = 3 and = 60 episodes of urinary incontinence, with no more than one incontinence-free day, as recorded in the 3-day bladder diary completed during the screening period
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1) patient currently uses clean intermittent catheterization (CIC) (at any frequency), or indwelling catheter, to manage their urinary incontinence
- •2) per investigator judgment, patient should be using CIC to empty their bladder even if currently not doing so
- •3) patient is unable or unwilling to use CIC post-treatment, if required
- •4) patient has had previous or current botulinum toxin therapy of any serotype for any urological condition
- •5) patient has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of randomization/day 1
- •6) patient has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
- •- elevated serum creatinine > 2 times the upper limit of normal
- •- current or previous uninvestigated hematuria (patients with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction of the investigator)
- •- interstitial cystitis in the opinion of the investigator
- •- bladder stones and/or bladder stone surgery at the time of screening or within 6 months prior to screening
- •- surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries > 1 year from screening for stress incontinence, uterine prolapse, rectocele, or cystocele
- •- urethral and/or bladder outlet obstruction, in the opinion of the investigator
- •7) patient has 24-hour total volume of urine voided > 3000 mL, collected over 24 consecutive hours during the 3-day bladder diary collection period during screening
- •8) patient has a post-void residual (PVR) urine volume of >150 mL at screening. Note: the PVR measurement can be repeated once; the patient is to be excluded if the repeated measure is above 150 mL
研究者
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