CTRI/2014/09/004999招募中4 期
A prospective, randomized, single blind study of ocular side effects of darifenacin and trospium in overactive bladder.
Dr Manjunatha R self0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female patients aged >18 and <80 years
- •Patients with a baseline score for urinary urgency of >=2 points, day time frequency >1 point and a total OABSS of >=3 points, with or without urgency urinary incontinence (UUI) episodes
- •Symptoms of OAB for at least 4 weeks
- •Patients with stable doses of alpha blockers or 5-alpha-reductase inhibitors for patients with benign prostatic hyperplasia were permitted with the limitation that a specific drug was used without a change in dosage and administration and was not replaced with another drug during the study period (observation and treatment phase).
排除标准
- •Serious heart disease,
- •Untreated angle-closure glaucoma,
- •Myasthenia gravis,
- •Gastric outlet and intestinal obstruction, paralytic ileus, gastric and intestinal atony or risk of urinary or gastric retention.
- •Residual urine volume >=100 mL (determined by abdominal sonography)
- •Strong possibility of prostate and bladder cancer
- •Acute active urinary tract infection
- •Women of childbearing age were required not to be pregnant or nursing, and to be using acceptable methods of contraception.
- •Concomitant treatments known to affect urinary bladder function like anticholinergics, antispasmodics, serotonin-noradrenaline-reuptake-inhibitors, TCA, first generation antihistaminics, cholinergic agonists, cholinesterase inhibitors (e.g. bethanecol, donepezil and rivastigmine), potent inhibitors of cytochrome CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), potent P-glycoprotein inhibitors (e.g. cyclosporine and verapamil), aluminum antacids, antiparkinson and antipsychotic drugs, Calcium channel blockers, opioids, muscle relaxants, angiotensin-converting enzyme inhibitors, anticoagulants.
- •Patients on digoxin or metformin
- •Severe hepatic or renal dysfunction
- •Participation in a clinical trial within 30 days before study entry.
- •History of alcohol or drug abuse
- •Currently suffering from serious disease or malignancy
- •Significant psychiatric problems
- •Dry eyes, ocular surface disorders, glaucoma, or issues that could affect visual acuity or accommodation (such as cataract, macular degeneration, or history of ocular surgery)
研究者
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