EUCTR2007-004126-24-PT进行中（未招募）不适用
A placebo controlled randomized, 12-week, dose-ranging, double-blind study versus placebo using tolterodine as a study calibrator, to evaluate efficacy and safety of SSR240600C in women with overactive bladder including urge urinary incontinence
适应症
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
- 800
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
- •Female patients ( 18 to 70 years of age, inclusive) diagnosed with overactive bladder (OAB) with symptoms of:
- •Urge urinary incontinence (UUI) at least 5 UUI episodes per week, AND urgency at least 1 episode per 24 hrs, AND urinary frequency at least 8 micturitions per 24hrs.
- •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
- •Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history;
- •Urinary incontinence due to cause other than detrusor overactivity (e.g., overflow incontinence);
- •Urinary retention or other evidence of poor detrusor function;
- •Pain during voiding or bladder pain without voiding;
- •History of radiation cystitis or history of pelvic irradiation;
- •History of interstitial cystitis or bladder related pain syndrome(s);
- •Post-void residual volume of urinary bladder >10ml;
- •Current UTI or frequent UTIs (i.e., greater than or equal to 5 UTIs per year);
- •Concomitant use of medication(s) that are CYP3A substrate(s) with narrow therapeutic range, or potent inhibitor(s) of a CYP450 isoenzyme 3A4, or any treatment with this/these medications within the 4 weeks prior to the study.
研究者
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