NCT00802373已完成3 期
Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,355
- 主要终点
- Change from baseline in mean number of micturitions per 24 hours
研究概览
简要总结
Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At study entry:
- •Patient is willing and able to complete the micturition diary correctly
- •Symptoms of overactive bladder (including urinary frequency, urgency or urge incontinence) for >= 3 months
- •At randomization:
- •Patient must experience frequency of micturition on average >= 8 times per 24 hour period during the 3 day micturition diary period
- •Patient must experience at least one of the following symptoms during the 3 day micturition diary period:
- •At least 3 episodes of urinary incontinence or,
- •Patients must exhibit urgency at least 3 times
排除标准
- •At study entry:
- •Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
- •Clinically significant outflow obstruction (at the discretion of the investigator)
- •Significant post void residual volume (PVR>200ml)
- •Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- •Patient with a neurological cause for abnormal detrusor activity
- •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
- •Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- •Non drug treatment including electrostimulation therapy or start of a bladder training program during the 2 weeks prior to entry into, or during the study
- •Use of drugs intended to treat urinary incontinence
- •Diabetic neuropathy
- •Known or suspected hypersensitivity to solifenacin, tolterodine, other anticholinergics or lactose
- •Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
- •Participation in any clinical trial within 30 (90 in the UK) days prior to randomisation
- •Employees of the Yamanouchi Group, third parties associated with the study, or the study site
- •At randomization:
- •Patient who did not complete the micturition diary according to the instructions
- •Total daily urine volume > 3000 ml as verified in the micturition diary
研究组 & 干预措施
I
Experimental
Solifenacin succinate 5/10mg
干预措施: Solifenacin succinate (Drug)
II
Experimental
Tolterodine 4mg
干预措施: Tolterodine (Drug)
结局指标
主要结局
Change from baseline in mean number of micturitions per 24 hours
时间窗: Weeks 4, 8 and 12
次要结局
- Change from baseline in mean urgency frequency per 24 hours(Weeks 4, 8 and 12)
- Change from baseline in mean volume voided per micturition(Weeks 4, 8 and 12)
- Change from baseline in number of pads used(Weeks 4, 8 and 12)
- Change from baseline in mean nocturia episodes per 24 hours(Weeks 4, 8 and 12)
- Patient assessment of treatment benefit(Weeks 4, 8 and 12)
- Percentage of patients requiring an increase in the dose of the study medication(Weeks 4, 8 and 12)
- Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours(Weeks 4, 8 and 12)
- Change from baseline in patient perception of bladder condition(Weeks 4, 8 and 12)
- Physician assessment of treatment benefit(Weeks 4, 8 and 12)
研究者
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