EUCTR2006-002361-39-DE进行中（未招募）不适用
A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 Screening
- •Male and female patients aged 18 years with the diagnosis of multiple sclerosis
- •Neurogenic detrusor overactivity without DSD as confirmed by the baseline
- •urodynamics during this study.
- •Symptoms of OAB as defined by
- •- micturitions/day 8 and more, respectively
- •- urgency episodes per day 1 and more, respectively
- •Patients capable of understanding the given information and having signed
- •Patient Informed Consent Form after full discussion of the research nature of the
- •treatment and its risks and benefits
- •Patients capable of independently completing the bladder diary
- •Patients capable of independent toileting
- •Patients able to swallow the study medication in accordance to the protocol
- •Body Mass Index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2
- •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 Screening
- •Treatment with drugs known to affect mainly the urinary bladder function
- •Participation in a bladder-training program or any electro stimulation therapy
- •within the 2 weeks prior to Visit 1
- •Low compliance bladder (Compliance < 20 mL/cm H2O),
- •Indwelling catheter or intermittent self-catheterization
- •Patients with post-void residual (PVR) urinary volume >200 mL at Baseline
- •Urinary retention or clinically significant bladder outlet obstruction
- •Low pressure reflux
- •Clinically predominant and bothersome stress urinary incontinence
- •Neurological diseases other than multiple sclerosis affecting
- •Any clinically significant congenital or acquired disorder of the urogenital tract
- •Any urogenital surgery within 12 months prior to Visit 1
- •Any history of pelvic radiation therapy
- •Females with urinary symptoms secondary to cystocele or pelvic organ prolapse
- •greater than stage 2
- •Chronic persistent local pathology that in the opinion of the investigator may lead
- •to urinary symptoms, such as one of the genito-urinary pain syndromes, interstitial
- •cystitis; fecal impaction and severe constipation
- •Three or more urinary tract infections per year over the preceding 12 months
- •Unexplained haematuria
- •Any history of carcinoma of the urogenital tract.
- •Concomitant diseases in which the use of darifenacin is contraindicated
- •Significant medical problems, including but not limited to the following: uncontrolled
- •severe hypertension, uncontrolled severe heart failure, myocardial infarction in the
- •last 6 months, uncontrolled thyroid disease (unless the patient is on controlled
- •thyroid hormone for at least 3 months), or evidence (from direct questioning
- •and/or physical examination) of any clinically significant systemic disease that in
- •the investigator’s opinion makes the patient unfit to participate in the study
- •Evidence, based on laboratory tests done at Visit 1, of:
- •Hepatic disorder (ALT or AST > 1.5 x upper normal limit [ULN]; bilirubin > 1.2 x ULN
- •unless secondary to Gilbert’s disease in the opinion of the investigator)
- •Blood coagulation disorder (e.g. haemophilia)
- •Anemia (haemoglobin > 2 g/dL [20 g/L] below the lower limit of normal)
- •Currently receiving or have received the following medications within two weeks
- •prior to Visit 2 and at any time during the study:
- •- Cholinergic agonists and cholinesterase inhibitors e.g. bethanecol, donepezil,
- •rivastigmine
- •- Potent inhibitors of cytochrome CYP3A4 and potent P-glycoprotein inhibitors such
- •as cyclosporine and verapamil.
- •Treatment with an unstable dose of any drug having the potential for significant
- •anticholinergic side effects in the last 4 weeks prior to Visit 1
- •Women of child-bearing potential defined as all women physiologically capable of
- •becoming pregnant, unless they are using one or more of the following acceptable
- •methods of contraception: surgical sterilization (e.g. bilateral tubal ligation,
- •vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier
- •methods (any double combination of: hormonal IUD, male or female condom with
- •spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of
- •contraception may also include total abstinence at the discretion of the
- •investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-
- 另有 1 项未显示
研究者
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