EUCTR2004-002894-21-DE进行中（未招募）不适用
A 12-week, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety and tolerability of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d.) in patients aged = 65 years with overactive bladder - Not applicable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 399
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
- •1) Males and females aged 65 years and over
- •2) Give written informed consent by signing and dating an informed consent form
- •prior to prior to initiation of any study-related activities
- •3) Capable of independently completing the diary. At baseline (Visit 3), at least 5
- •days of the 7 day diary need to be completed for patients to be considered for
- •randomization.
- •4) Capable of independent toileting
- •5) Symptoms of OAB for at least six months prior to Visit 3
- •6) Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
- •= 1 UUIE on average per day and
- •= 10 episodes of micturition on average per day
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1) Treatment 2 weeks prior to Visit 2 with drugs known to mainly affect the urinary
- •bladder function or the external urethral sphincter (e.g., duloxetine).
- •2) A total daily urinary volume > 3000 ml and a mean volume voided per micturition
- •of > 300 ml as verified in the micturition diary before randomization
- •3) Clinically significant stress urinary incontinence (SUI) as determined by the
- •investigator - thorough review of anamnesis at visit 1; numbers of SUI <= 25% of
- •all incontinence episodes
- •4) Clinically significant bladder outlet obstruction as determined by investigator
- •5) Post-void residual (PVR) urinary volume > 100 ml at Visit 2 as assessed by
- •ultrasound or assessment perfomed by catheterization in female
- •6) Any clinically significant congenital or acquired disorder of the urinary tract or any
- •urinary bladder dysfunction (other than OAB)
- •7) Females with marked cystocele or other clinically significant Stage 3 or Stage 4
- •pelvic prolapse as defined by ICS
- •8) Intermittent urinary tract infections (UTIs) (3 or more UTIs per year over the
- •preceding 2 years) or acute UTI at Visit 1
- •9) History of chronic pain syndrome of the lower urinary tract, such as interstitial
- •cystitis and pelvic pain
- •10)Any history of carcinoma of the lower urinary tract
- •11)History of any carcinoma within the last 5 years
- •12)Patients with uninvestigated hematuria
- •13)Any urogenital surgery within 12 months prior to Visit 1; bladder or prostate
- •biopsy 30 days prior to Visit 1; instrumentation of the lower urinary tract
- •within 14 days prior to Visit 1
- •14)Any history of pelvic radiation therapy
- •15)Indwelling catheter or intermittent self-catheterization
- •16)Participation in a bladder-training program or any electro stimulation therapy
- •within 3 months prior to Visit 1 or at any time during the study
- •17)Chronic persistent local pathology that in the opinion of the investigator may
- •lead to urinary symptoms, e.g. fecal impaction and severe constipation (by the
- •Rome II Criteria definition as 2 or less bowel movements per week accompanied
- •by all, some or none of the following symptoms of straining, hard stool,
- •abdominal fullness and incomplete evacuation)
- •18)Concomitant diseases in which the use of anticholinergic drugs is
- •contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-
- •angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B
- •and C), severe ulcerative colitis, toxic megacolon
- •19)Having received the following medications:
- •Potent inhibitors of cytochrome CYP3A4 (e.g., protease inhibitors, ketoconazole
- •and itraconazole) or potent P-glycoprotein inhibitors such as cyclosporine and
- •verapamil (Note: Caution should be exercised in patients receiving
- •concomitant treatment with drugs that are potent inhibitors of CYP2D6 such as
- •paroxetine, terbinafine, quinidine and cimetidine or moderate inhibitors of
- •CYP3A4 such as fluconazole, grapefruit juice and erythromycin) taken within
- •two weeks prior to Visit 2
- •Cholinergic agonists, e.g., bethanecol taken within two weeks prior to Visit 2
- •Unstable dose in the last three months of drugs with significant
- •anticholinergic effects such as SSRI's (e.g.paroxetine), tricyclic antidepressants
- •(e.g. imipramine), and first generation antihistamines. However, trazadone is
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