A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vantia Ltd
- 入组人数
- 152
- 试验地点
- 19
- 主要终点
- Change in the mean number of nocturnal voids per night
研究概览
简要总结
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
详细描述
Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.
The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged ≥18 years (no upper limit) with nocturia
- •Generally well (concomitant illness/conditions well controlled)
- •Serum sodium within the normal limits
- •Normal or not clinically significant prostate specific antigen levels
- •Able to comply with the requirements of the study
- •Provide written informed consent
排除标准
- •Prostatic cancer
- •Signs or symptoms of heart failure
- •Peripheral pitting oedema extending ≥10 cm above the ankle
- •Palpable bladder or pelvic mass on abdominal examination
- •Enuresis or night-time incontinence
- •Excessive nocturnal void frequency
- •Sleep disorders
- •Diabetes insipidus or uncontrolled diabetes mellitus
- •Presence of blood or glucose in the urine on urinalysis that is clinically significant
- •Urinary tract infection
- •Polydipsia
- •Syndrome of inappropriate antidiuretic hormone secretion
- •Body mass index ≥35
- •High calcium levels or low potassium levels
- •Other protocol defined eligibility criteria may apply
研究组 & 干预措施
VA106483 1mg
干预措施: VA106483 (Drug)
VA106483 2mg
干预措施: VA106483 (Drug)
VA106483 4mg
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 number of nocturnal voids per night
时间窗: 70 days
次要结局
- Mean duration of first sleep period(70 days)
- Change in nocturia-related quality of life(70 days)
- Incidence and frequency of adverse events(70 days)
- Frequency of hyponatraemia(70 days)
- Change from baseline in safety laboratory parameters(70 days)