EUCTR2007-000192-42-IT进行中（未招募）不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND
ALLERGA0 个研究点目标入组 260 人开始时间: 2007年7月31日最近更新:
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
- 260
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
- •- Patient is male or female, aged 18 to 80 years old. - Written informed consent has and written Authorization of Use of sensitive personal data - Patient has urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented patient history. In addition: Spinal cord injury patients must have a stable neurological injury level at T1 or below (cervical injuries are excluded) occurring ≥ 6 months prior to screening Multiple sclerosis patients must be clinically stable in the investigator?s opinion for ≥ 3 months prior to screening day and have an Expanded Disability Status Scale score ≤ 6.5. - Patient has detrusor overactivity (defined as a phasic rise in bladder pressure during the filling phase determined by urodynamics) demonstrated during the screening period or Day 1 (prior to randomization). - Patient has not been adequately managed with one or more anticholinergics for their urinary incontinence, in the opinion of the investigator (inadequate response or intolerable side effects after at least one month of anticholinergic therapy on an optimized dose). - For patients taking anticholinergic medication for their neurogenic overactive bladder, dose is stable - Patient has a negative pregnancy result if female and of childbearing potential. - Patient experiences ≥ 14 episodes of urinary incontinence per week with no more than 2 incontinent-free days determined by completion of patient bladder diary during the screening period. - Patient currently uses or is willing to use clean intermittent catheterization to empty the bladder
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- any pelvic or urological abnormalities - elevated serum creatinine > 2 times the upper limit of normal - history of or currently unexplained hematuria - interstitial cystitis - bladder stones - surgery or other bladder disease - Patient has had previous or current botulinum toxin therapy - Patient has been immunized for any botulinum toxin serotype. - bladder cancer or suspect - prostate cancer. - detrusor compliance below 20 mL/cm H2O 8. Patient has 24 hour total volume voided > 3000 mL of urine - Patient has a post void residual volume above 150 mL - active genital infection - Patient uses any anti-platelet or anticoagulant therapy - hemophilia or other bleeding diatheses. - concurrent treatment or treatment within 6 months of Randomization/Day 1 with capsaicin or resiniferatoxin. - Patient is currently using or plans to use an implanted or non-implantable electrostimulation/neuromodulation device for treatment of overactive bladder. - known allergy or sensitivity to any components of the study medication, or any other products associated with the treatment and general study procedures. - pregnancy, nursing or planning a pregnancy during the study
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