EUCTR2005-001936-59-GB进行中（未招募）1 期
A multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-response study of the safety and efficacy of a single treatment of BOTOX® (botulinum toxin type A) purified neurotoxin complex in patients with idiopathic overactive bladder with urinary urge incontinence.
ALLERGAN LTD0 个研究点目标入组 270 人开始时间: 2005年6月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
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
入选标准
- •All inclusion criteria are listed since they are all equally important.
- •Patient is male or female, aged 18 to 85 years old
- •Patient weighs = 50 kg (110 lbs)
- •Patient has symptoms of idiopathic overactive bladder (frequency and urgency) with urinary urge incontinence for a period of at least 6 months immediately prior to screening day -15, determined by documented patient history
- •Patient is able to complete study requirements including electronic bladder diary completion, using the toilet without assistance (patient’s incontinence is not due to inability to reach the toilet) and attend all study visits, in the opinion of the investigator
- •Written informed consent has been obtained
- •Patient has negative pregnancy test result if female and of child-bearing potential
- •Written Data Protection consent has been obtained
- •Patient experiences =8 episodes of urinary urge incontinence, with no more than one incontinence-free day, determined by completion of patient bladder diary collected over seven consecutive days during the screening period (screening day -14 to randomization day 0)
- •Patient experiences urinary frequency, defined as an average of =8 micturitions per day (normal voids only), with no more than one micturition-free day, determined by completion of patient bladder diary collected over seven consecutive days during the screening period (screening day -14 through randomization day 0)
- •Patient has not been adequately managed with one or more anticholinergic drugs for their overactive bladder symptoms, in the opinion of the investigator. Not adequately managed is defined as an inadequate response to or intolerable side effects after at least one month of anticholinergic therapy on an optimized dose
- •Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment
- •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
- •All exclusion criteria are listed since they are all equally important.
- •Patient has symptoms of overactive bladder due to any known neurological reason e.g. spinal cord injury, multiple sclerosis, cerebral vascular accident, Alzheimer’s disease, Parkinson’s disease, etc.
- •Patient has received anticholinergic or sympathomimetic medication for the treatment of overactive bladder within 21 days of randomization day 0
- •Patient uses clean intermittent catheterization (CIC) to manage their urinary incontinence
- •Patient has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than overactive bladder”, that may impact bladder function. Note: Patient is currently using or has not removed a previously implanted electrostimulation/neuromodulation device for treatment of urinary incontinence (the latest time the device should have been removed is 6 weeks prior to randomization); use of other non-implantable electrostimulatory devices is also exclusionary.
- •Patient has history or current diagnosis of bladder cancer or has urine cytology results which may indicate bladder cancer (e.g., suspicious results or diagnostic of malignancy) at screening day -15
- •Patient has a post void residual urine volume >200mL at screening day -15
- •24 hour total volume voided > 3000 mL of urine determined by completion of patient bladder diary collected during the seven consecutive days during the screening period (day -14 to day 0)
- •Patient has a predominance of stress incontinence, determined by patient history, in the opinion of the investigator
- •Patient is male with previous or current diagnosis of prostate cancer. Patients with a PSA level greater than 4.0 ng/mL will require a biopsy to rule out prostate cancer, unless a prostatic biopsy has been performed within the past 12 months
- •Patient is male, >40 years of age and has a urine flow rate <12 cc/second at screening day -15
- •Patient has serum creatinine level >2 times the upper limit of normal at screening day -15
- •Patient has a history of two or more treated urinary tract infections within 6 months of screening day -15
- •Patient has urinary infection defined as a bacteriuria count of >105/mL conjoint with leukocyturia >5/hpf at screening day -15
- •Patient has asymptomatic urinary infection, defined as positive nitrites, blood and/or leukocyte esterase on urine dipstick reagent strip test at randomization day 0
- •Patient has history of unexplained hematuria or unexplained hematuria if >5 RBCs/hpf are present at screening day -15 or randomization day 0)
- •Patient has active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening day -15
- •Patient has a history of interstitial cystitis, in the opinion of the investigator
- •Patient has evidence of urethral obstruction, in the opinion of the investigator at screening day -15 or randomization day 0
- •Patient has a detrusor compliance on urodynamic evaluation of = 20 mL/cmH20 at randomization day 0
- •Patient uses anti-platelet or anti-coagulant therapy within 3 days prior to randomization day 0. Note: Some medications can be withheld
研究者
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