EUCTR2010-022611-19-EE进行中（未招募）不适用
A Phase 2a, multicentre, parallel-group, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of 2 doses of XEN-D0501 in the treatment of idiopathic overactive bladder (OAB).
Xention Limited0 个研究点目标入组 300 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- Female
入选标准
- •1. Willing and able to give written, informed consent
- •2. Females, 40-80 years of age. If under 60 years of age, subjects must not be of child bearing potential (i.e., postmenopausal [defined as amenorrheic for at least 1 year (off hormone replacement therapy) AND have a serum follicle-stimulating hormone (FSH) level of at least 30 IU/L at Visit 1], or have undergone a hysterectomy or bilateral oophorectomy, or have other documented evidence of infertility. Note: Tubal ligation is not acceptable)
- •3. A current primary diagnosis of OAB (in accordance with International Continence Society [ICS] guidelines) with medical history indicating a mean of = 8 voids/day and 1 or more episodes of urgency or incontinence/day
- •4. Evidence of frequency in combination with moderate to severe urgency episodes from the Placebo Run-in Period micturition diary, with a mean of = 8 voids/day and a total of =3 episodes of moderate to severe urgency or incontinence during the 3 day urinary diary period before randomisation at Visit 2
- •5. Body mass index (BMI) between 18 and 32 kg/m2
- •6. Agree to refrain from blood donation during the course of the study
- •7. Agree to stop taking any existing medication that may interfere with study evaluation (e.g. diuretics, antimuscarinics, potent CYP3A4 inhibitors and antidepressants) from the start of Placebo Run-in Period to the final Follow-up Visit.
- •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
- •1. Clinically significant unstable medical condition (other than idiopathic OAB) that might in the Investigator’s opinion interfere with assessment or follow-up
- •2. History or evidence of urinary retention or bladder outlet obstruction (defined as post-void residual volume >50mL or uroflow rate <15mL/sec with a void volume at least 120 ml)
- •3. Current (within past 3 months) bladder pain
- •4. History of QTc prolongation or QTc interval =470 msec at Visit 1
- •5. Predominant stress urinary incontinence versus urge urinaryincontinence based on subject history (e.g. exclude patients whose predominant symptoms are incontinence related to cough, sneezing, straining, etc.)
- •6. Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis)
- •7. Anatomic or structural abnormalities possibly causing urinary urgency or incontinence
- •8. Surgery on the lower urinary tract within previous 3 months of the baseline assessment (Visit 1)
- •9. History of =4 urinary tract infections (UTIs), interstitial cystitis or haematuria of unknown cause, or use of indwelling catheter in the previous 12 months or a current diagnosis of UTI as determined by the investigator;
- •10. Electro-stimulation therapy or starting bladder training or physiotherapy for bladder control within previous 2 weeks of Visit 1
- •11. Scheduled surgery or procedure during the study period
- •12. History (within previous 1 year of consent) of alcohol or substance dependence (except nicotine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV TR) criteria
- •13. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor
- •14. Existing non-malignant tumours that could compromise the function and/or anatomy of the lower urinary tract
- •15. Urine output >3.0L/day
- •16. Concomitant disease or condition (or its treatment) which could interfere with the conduct of the study, or which would in the opinion of the Investigator, pose a risk to the subject in this study
- •17. Participation in an investigational drug or device study within 30 days prior to Visit 1 or within 5 half lives of the drug, whichever is the greater.
- •18. Botulinum toxin treatment within previous 9 months of Visit 1
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