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

sanofi-aventis recherche & développement0 个研究点目标入组 800 人开始时间: 2007年10月8日最近更新: 2021年10月8日

试验速览

暂无简介。

•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

•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.

发起方