NCT00629642已完成4 期
A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 249
- 主要终点
- Change from baseline in maximum cystometric capacity
研究概览
简要总结
A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis
详细描述
A clinical study to compare the efficacy and safety of solifenacin succinate in patients with neurogenic detrusor overactivity. In this randomized, double blind, double dummy study solifenacin will be compared to placebo and an active comparator, oxybutynin hydrochloride. Patients will be randomized to one of four treatment arms; solifenacin 10mg, solifenacin 5mg, placebo or oxybutynin 15mg. Patients will be assessed over a four week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained
- •Subjects with neurogenic detrusor overactivity due to:
- •Multiple sclerosis(MS)(EDSS≤8) or
- •Spinal cord injury(SCI)(partial or complete lesions)
- •MS or SCI symptoms should be stable for >= 6 months
- •Neurogenic detrusor overactivity symptoms should be stable for >= 6 months
- •Subject is willing and able to perform clean, intermittent, catheterization, if required
- •Subject is willing and able to take study medication in compliance with the protocol
排除标准
- •Subjects with neurogenic detrusor overactivity due to Parkinson's or cerebrovascular disease
- •Subjects with Sjögren's Syndrome or any similar symptoms
- •Subjects with evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- •Subjects with stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator
- •Subjects with evidence of pressure sores >= grade 2
- •Subjects with a history of bladder sphincterotomy
- •Subjects with known history of vesico-ureteral reflux without upper urinary tract infection
- •Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber
- •Subjects undergoing hemodialysis
- •Subjects with severe hepatic impairment
- •Concurrent use of drugs intended to treat symptoms of overactive bladder
- •Use of antidepressants or muscle relaxants which have not been administered at a constant dose for >= 3 months
- •Use of non-drug treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin and vanilloids therapy in the six months prior to the commencement of the study
- •Use of permanent, indwelling catheters
- •Known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti cholinergics or lactose
- •Concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
- •Pregnant women, women who intend to become pregnant during the study, women of childbearing potential who are sexually active and practicing an unreliable method of birth control or women who will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
- •Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer
- •Employees of the Astellas Group, third parties associated with the study, or the study site
- •Subjects with maximum bladder capacity >= 400ml at visit 2
研究组 & 干预措施
I.Solifenacin succinate 10mg (2x5mg 1/day)
Experimental
Oral
干预措施: Solifenacin Succinate (Drug)
II.Solifenacin succinate 5mg (5mg 1/day)
Experimental
Oral
干预措施: Solifenacin Succinate (Drug)
III.Oxybutynin hydrochloride 15mg (5mg 3/day)
Active Comparator
Oral
干预措施: Oxybutynin Hydrochloride (Drug)
IV. Placebo
Placebo Comparator
Oral
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in maximum cystometric capacity
时间窗: 4 Weeks
次要结局
- Change from baseline in bladder volume at first involuntary contraction(4 Weeks)
- Change from baseline in pressure at first leak(4 Weeks)
- Change from baseline in volume at first leak(4 Weeks)
- Change from baseline in maximum detrusor pressure(4 Weeks)
- Change from baseline in micturition or catheterization frequency(4 Weeks)
- Change from baseline in incontinence episodes(4 Weeks)
- Incidence and severity of adverse events(4 Weeks)
研究者
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