A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vantia Ltd
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Change in the mean nocturnal urine voids
研究概览
简要总结
The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.
详细描述
Fedovapagon 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 the complaint that the individual has to wake at night one or more times to void, 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 (BPH) 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).
The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 55 or over
- •History and/ or symptoms of Nocturia (2 - 5 voids per night)
- •Generally well (concomitant illness / conditions well controlled)
- •Serum sodium, potassium, chloride and bicarbonate within normal limits
- •No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination
- •Prostate specific antigen (PSA) within the normal range or not considered clinically significant
- •Ability to comply with the requirements of the study
- •Written informed consent.
排除标准
- 未提供
研究组 & 干预措施
fedovapagon 1 mg
Once daily oral dose of 1 mg fedovapagon for 12 weeks
干预措施: fedovapagon 1 mg (Drug)
fedovapagon 2 mg
Once daily oral dose of 2 mg fedovapagon for 12 weeks
干预措施: fedovapagon 2 mg (Drug)
fedovapagon 4 mg
Once daily oral dose of 4 mg fedovapagon for 12 weeks
干预措施: fedovapagon 4 mg (Drug)
sugar pill
Once daily oral dose of placebo for 12 weeks
干预措施: Placebo ( sugar pill) (Drug)
结局指标
主要结局
Change in the mean nocturnal urine voids
时间窗: 12 weeks
次要结局
- Change in the mean nocturnal urine voids(4 weeks)
- Change in the mean time to first nocturnal void(12 weeks)
- Change in Nocturia-related quality of life (N-QOL)(12 weeks)