A Randomised, Double-blind, Placebo-controlled, Five-way Cross-over Dose Response Study to Determine the Effect of VA106483 on Nocturnal Urine Volume in Elderly Male Subjects With Nocturia and Benign Prostatic Hypertrophy (BPH)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vantia Ltd
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the mean nocturnal urine volumes
研究概览
简要总结
The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.
详细描述
VA106483 is a selective vasopressin V2-receptor (V2-receptor) agonist that is being developed for the treatment of nocturia.
The antidiuretic effect of V2-receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and nocturia.
Nocturia, defined as waking to void at least once per night between periods of sleep, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It is the most bothersome symptom of benign prostatic hypertrophy and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (nocturnal polyuria).
Correlation between nocturnal urine volume and nocturnal void frequency has been demonstrated in previous studies of V2-receptor agonists.
The purpose of this study is to determine the dose response relationship of VA106483 and nocturnal urine volumes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)
排除标准
- •Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study
- •Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
- •Other protocol defined eligibility criteria may apply
研究组 & 干预措施
VA106483 0.5 mg
干预措施: VA106483 (Drug)
VA106483 1 mg
干预措施: VA106483 (Drug)
VA106483 2 mg
干预措施: VA106483 (Drug)
VA106483 4 mg
干预措施: VA106483 (Drug)
Sugar pill
干预措施: VA106483 (Drug)
结局指标
主要结局
Change in the mean nocturnal urine volumes
时间窗: 20 days
次要结局
- Change in the mean nocturnal void frequency(20 days)
- Change in mean time to first void(20 days)
- Change in frequency of daytime voids(20 days)
- Change in mean volume of daytime voids(20 days)
- Change in mean nocturnal urine osmolality(20 days)
- Change in mean daytime urine osmolality(20 days)
- Change in mean voided volumes(20 days)