NCT01018264已完成4 期
URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Number of Micturations Per 24 Hour Period
研究概览
简要总结
This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
- •Age 40 years to 80 years.
- •Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
- •Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale.
- •Women of child-bearing potential must use a reliable method of contraception.
- •Must be experiencing symptoms of overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months.
- •The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician).
- •The patient must have had a bladder scan within six months of the screening visit. This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline.
- •Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 months.
排除标准
- •Any illness that in the investigator's opinion preclude participation in this study.
- •Pregnancy or lactation.
- •Concurrent participation in another clinical study.
- •Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27).
- •Legal incapacity or limited legal capacity.
- •History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
- •Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit.
- •Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
- •Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
- •Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
- •History of narrow angle glaucoma.
- •Patients who have undergone pelvic radiation at any time.
- •Currently taking any of the following medications:
- •Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps)
- •Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril)
- •Tricyclic anti-depressants: amitriptyline (Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl), amoxapine (Asendin, Asendis, Defanyl, Demolox, Moxadil), clomipramine (Anafranil), desipramine (Norpramin, Pertofrane), imipramine (Antideprin, Deprenil, Deprimin, Deprinol, Depsonil, Dynaprin, Eupramin, Imipramil, Irmin, Janimine, Melipramin, Surplix, Tofranil), nortriptyline (Aventyl, Pamelor, Nortrilen), protriptyline (Vivactil), trimipramine (Stangyl, Surmontil, Rhotrimine)
- •Psychotropics: doxepin (Aponal, Adapine, Sinquan, Sinequan)
- •Anticholinergics/Antispasmodics: trihexyphenidyl (Artane, Aparkan), benztropine (Cogentin), oxybutynin (Ditropan, Ditropan XL, Lyrinel XL, Oxytrol), darifenacin (Enablex), emepronium, flavoxate (Urispas), meladrazine, propiverine, solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), trospium (Sanctura)
- •Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI): duloxetine (Cymbalta, Yentreve), Venlafaxine (Effexor, Effexor XR)
- •Arylalkylamines: pseudoephedrine (Sudafed)
- •Anti-androgen: bicalutamide (Casodex, Cosudex, Calutide, Kalumid), finasteride (Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX), dutasteride (Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost), Zoladex (goserelin acetate), Eulexin (flutamide), Lupron (leuprolide acetate)
- •Antihypertensives: prazosin (Minipress, Vasoflex, Hypovase)
- •Estrogens (Menest, Premarin, Premarin IV)
- •Acetylcholinesterase inhibitors (rivastigmine (Exelon), galantamine, (Reminyl, donepezil (Aricept), Tacrine.
- •Memantine (Namenda)
- •Urinary obstruction in male PD patients as diagnosed by a urologist
- •Active urinary tract infection.
- •Patients with a history of chronic severe constipation (by self report)
研究组 & 干预措施
solifenacin succinate (VESIcare)
Experimental
干预措施: solifenacin succinate (VESIcare) (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of Micturations Per 24 Hour Period
时间窗: 12 weeks
The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries.
次要结局
- Number of Urinary Incontinence Episodes Per 24 Hour Period(12 weeks)
- Number of Nocturia Episodes Per 24 Hour Period(12 weeks)
- Unified Parkinson's Disease Rating Scale (UPDRS) Total(12 weeks)
- Parkinson's Disease Quality of Life Scale (PDQOL)(12 weeks)
研究者
Theresa Zesiewicz, MD
Professor of Neurology
University of South Florida
研究点 (3)
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