EUCTR2012-003159-12-DE进行中（未招募）不适用
Efficacy of propiverine hydrochloride extended release (ER) 45 mg in patients with neurogenic detrusor overactivity – an active-controlled single center crossover trial
适应症
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
- •1.Patients with stable neurogenic detrusor overactivity (NDO) due to spinal cord injuries.
- •2.Ability to understand the patient information and presence of a personally signed and dated informed consent to participate in the study before completing any study related procedures.
- •3.Female and male patients aged 18 years or older at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period.
- •4.Primarily proven NDO with evidence of reflex detrusor contractions in previous pressure-flow-studies.
- •5.Ability to practice clean intermittent catheterization (by the patient himself or a nurse/relative) at least 4 to 6 times daily.
- •6.The patient is co-operative and without time-limit available for the entire study duration.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Acute urinary tract infection (= 105 bacteria/ml urine) as defined by the investigator.
- •2.Multiple sclerosis and other systemic neurological disease under unstable conditions leading to voiding and/or bladder storage problems.
- •3.Botulinum toxin injections into the bladder within the last 12 month.
- •4.Bladder surgery (e.g. augmentation cystoplasty) or stomata for catheterization
- •(e.g. Mitrofanoff, Mainz pouch).
- •5.Sacral nerve stimulation (neuromodulation) or electrostimulation therapy within the last 4 weeks before randomization into the study.
- •6.Presence of bladder or ureteral stones.
- •7.Surgeries of the lower genitourinary tract within the last 6 months before randomization (e.g. prostatectomy, hysterectomy, tumor surgery) that endanger the integrity of the study in the opinion of the investigator.
- •8.Medical history of previous radiotherapy of the bladder, prostate, or pelvis.
- •9.Medical history of cancer of the bladder, prostate, or pelvis that endanger the integrity of the study in the opinion of the investigator.
- •10.Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis) that endanger the integrity of the study in the opinion of the investigator.
- •11.Medical history of cardiac insufficiency (NYHA stage IV).
- •12.Evidence of severe renal, hepatic or metabolic disorders that endanger the integrity of the study in the opinion of the investigator and/or that are confirmed by clinical significant laboratory results.
- •13.Medical history of pre-existing medical contraindications for antimuscarinics (e.g. obstruction of the bowel, Barrett syndrome, toxic megacolon, severe colitis ulcerosa, bladder or intestinal atony, significant degree of bladder outflow obstruction where urinary retention may be anticipated, pollakiuria of cardiac or renal genesis, tachyarrhythmia, angle-closure glaucoma, myasthenia gravis).
- •14.Known hypersensitivity to propiverine hydrochloride or excipients contained in the trial medication (e.g. lactose monohydrate, coloring agent cochineal red), respectively.
- •15.Concomitant medication known to have a potential to interfere with the trial medication or the goals of the trial (see section 8.4.6).
- •16.Pregnant or breast-feeding women or women of childbearing potential without using any reliable contraceptive methods.
- •17.Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study.
- •18.Current or history of impaired renal function as indicated by clinically significantly abnormal creatinine or urea values and abnormal creatinine clearance calculated with the Larsson formula.
- •19.Participation in another clinical trial with an investigational medicinal product within the last month prior to randomization.
- •20.An inability to swallow all investigational medicinal products.
研究者
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