EUCTR2005-005546-39-SE进行中（未招募）不适用
SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN WITH SIMPLIFIED BLADDER TRAINING VERSUS SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN ALONE IN A PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, OVERACTIVE BLADDER SYMPTOM STUDY - SOLAR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 706
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
- •At study entry:
- •Male or female subject aged MT 18 years
- •Written informed consent has been obtained.
- •Subject is capable of completing the simplified bladder training regimen correctly.
- •Subject is willing and able to complete the micturition diary correctly.
- •Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for more than / equal to 3 months.
- •At randomization:
- •Subject must experience the following symptoms during the 3 day micturition diary period: At least 3 episodes of urge incontinence or at least 3 episodes of urgency.
- •Subject must experience frequency of micturition on average more than / equal to 8 times per 24-hour period during the 3-day micturition diary period
- •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
- •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 practicing 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 (for female subjects confirmed by a cough provocation test).
- •Subject 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.
- •Subjects with narrow angle glaucoma, urinary or gastric retention or subjects considered at risk of these conditions. Subjects with urinary frequncy due to chronic heart failure or any other medical condition which in the opinion of the investigator excludes a diagnosis of OAB or makes the use of anticholinergics contra-indicated.
- •Non-drug treatment for OAB including electrostimulation therapy and pelvic floor exercises in the four weeks prior to the commencement of the study (or during the study apart from those included in the study bladder training instructions).
- •Subject who has received cognitive bladder training in the last 6 months.
- •Subject who intends to commence bladder training other than the study regimen during the study. (Any bladder training outside of the study regimen should be postponed until after the study).
- •Use of drugs intended to treat urinary incontinence, concomitant use of a strong CYP3A4 inhibitor, e.g. Ketoconazole (see appendix 1).
- •Myasthenia gravis or diabetic neuropathy
- •Known or suspected hypersensitivity to solifenacin succinate, other anticholinergics or lactose.
- •Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study. This includes a history of severe renal (GFR LT30 mL/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, bladder obstruction or chronic and severe constipation requiring treatment.
- •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.
- •At randomization:
- •Subject who did not complete the micturition diary according to the instructions.
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