EUCTR2012-003255-11-BE进行中（未招募）不适用
A Study Evaluating the Efficacy and Safety of BOTOX® and Solifenacin in Patients with Overactive Bladder and Urinary Incontinence
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 345
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 is male or female, aged = 18 years old.
- •2. Patient weighs = 40 kg (88 lbs).
- •3. Patient has OAB and urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented patient history
- •4. Patient experiences = 3 episodes of urinary urgency incontinence, with no more than 1 urinary urgency incontinence-free day, in the 3-day patient bladder diary completed during the screening period (see Section 6.3.4 Bladder Diary).
- •5. Patient experiences urinary frequency, defined as an average of = 8 micturitions (toilet voids) per day ie, a total of = 24 micturitions in the 3-day patient bladder diary completed during the screening period (see Section 6.3.4 Bladder Diary).
- •6. Patient has not been adequately managed with one or more anticholinergic agent for treatment of their OAB symptoms, in the opinion of the investigator. Not adequately managed is defined as:
- •oan inadequate response after at least a documented 4-week period of anticholinergic therapy on an optimized dose(s) ie, patient was still incontinent despite anticholinergic therapy, or
- •olimiting side effects after at least a documented 2-week period of anticholinergic therapy on an optimized dose(s).
- •An optimized dose is defined as an approved dose for the indication of OAB
- •7. Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder at any time after study treatment, if it is determined to be necessary by the investigator
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •1. Patient has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer’s disease, Parkinson’s disease, etc)
- •2. Patient has a predominance of stress incontinence, in the opinion of the investigator, determined by patient history
- •3. Patient has had previous or current therapy for OAB with solifenacin (any dose).
- •4. patient has received anticholinergics or any other medications or therapies to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
- •5. Patient uses CIC or indwelling catheter to manage their urinary incontinence.
- •6. Patient has a 24-hour total volume of urine voided > 3000 mL, collected over 24 consecutive hours during the 3-day bladder diary collection period prior to randomization/day 1
- •7.Patient has had previous or current botulinum toxin therapy of any serotype for any urological condition (or for any other condition within 12 weeks of randomization/day 1).
- •8. Patient has a history or evidence of uncontrolled narrow-angle glaucoma.
- •9. Patient has received therapy with ketoconazole or other potent cytochrome P450 3A4 (CYP3A4) inhibitors, within 7 days of the start of the screening period procedures.
- •10. Patient has serum creatinine level > 2 times the upper limit of normal at screening.
- •11. Patient has liver function tests (bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) > 1.5 times the upper limit of normal at screening.
- •12. Patient has decreased gastrointestinal motility, in the opinion of the investigator.
- •13. Patient has a known hypersensitivity to solifenacin, one of its components, including lactose, or to any other anticholinergics
- •14. Patient has a history of congenital or acquired QT prolongation
- •15. patient has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function including but not limited to:
- •o bladder stones and/or bladder stone surgery at the time of screening or within 6 months prior to screening
- •o surgery (including minimally invasive surgery) within 1 year of screening for stress incontinence, uterine prolapse, rectocele, or cystocele
- •o current or planned use of an electrostimulation/neuromodulation device (including posterior tibial nerve stimulation) for treatment of urinary incontinence (if a device is still implanted it must be inactive 4 weeks prior to randomization/day 1 and for the duration of the study); use of other nonimplantable electrostimulatory devices are also exclusionary.
- •16. Patient has evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator at screening or randomization/day 1
- •17. Patient has a PVR urine volume of > 100 mL at screening. The PVR measurement can be repeated once; the patient is to be excluded if the repeated measure is above 100 mL.
- •18. Patient has had urinary retention or an elevated PVR urine volume that has been treated with an intervention (such as catheterization) within 6 months of screening. Note: voiding difficulties as a result of surgical procedures that resolved within 24 hours are not exclusionary
研究者
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