NCT00553657已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Standardization of Fluid Intake on the Variability of Measured Voiding Parameters in Female Patients With Idiopathic Overactive Bladder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Variability of change from baseline in mean volume per void measured on 3 consecutive days.
研究概览
简要总结
The purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for Overactive Bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period.
- •Eligible patients must have signed the informed consent and must meet all inclusion and exclusion criteria as determined during the screening visit.
排除标准
- •Any abnormality identified on the screening examination or any other medical condition or circumstance making the patient unsuitable for participation in the study based on the Investigator's and Medical Monitor's assessment
- •Any contraindication to Detrol LA or other anti-muscarinic medications
- •Inability to consume 10 cc/kg of fluid within 30 minutes
- •Regular alcohol consumption averaging ³7 drinks/week for women (1 drink = 100mL of wine or 285mL of beer or 30mL of hard liquor)
- •Positive urine drug or alcohol at screening at screening
- •Average blood pressure measurements systolic ≥140 or diastolic ≥90 at screening at screening
- •QTcB value ≥ 450 msec at screening
- •Poorly-controlled diabetes mellitus or hypertension, as evidenced by a change in medication within the 2 months prior to initiation of the study
- •History of urinary retention or gastric retention
- •Known history of narrow-angle glaucoma
- •History of QT prolongation
- •Known reduction in hepatic or renal function
- •Concomitant Use of loop diuretics (eg. Furosemide)
- •Concomitant use of a medication that is a potent inhibitor of CYP3A4
- •Class IA or Class III antiarrhythmic medications
- •Patient is unable and/or unwilling to adhere to Lifestyle Guidelines
- •For women of child bearing potential, a positive serum β-hCG at screening or pre-dose, or an unwillingness to agree to adequate contraception from the time of screening until the completion of the study:
- •Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening.
- •Presence of urinary tract infection within 4 weeks of screening.
- •Post-void residual of >150 mL (bladder ultrasound).
结局指标
主要结局
Variability of change from baseline in mean volume per void measured on 3 consecutive days.
时间窗: 3 consecutive days
次要结局
- Mean change from baseline in volume voided per void. Percent and actual change from baseline in maximum volume voided, number of micturitions, number of incontinence episodes, number of urgency episodes, and time to first void on 3 consecutive days.(3 consecutive days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic ResectionPancreatic CancerNCT01058746Memorial Sloan Kettering Cancer Center331
已完成
不适用
Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic ShockFluid TherapySeptic ShockHypotensionNCT02473718Washington University School of Medicine82
已完成
3 期
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical CystectomyBladder CancerNCT02145871Memorial Sloan Kettering Cancer Center282
已完成
3 期
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver ResectionLiver CancerNCT01596283Memorial Sloan Kettering Cancer Center135
已完成
早期 1 期
The Effects of Increased IV Hydration on Nulliparous Women Undergoing an Induction of LaborForced or Induced, Affecting Fetus or Newborn LaborNCT02989571MemorialCare Health System180