NCT03116191已完成2 期
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change from baseline in mean number of nocturnal voids
研究概览
简要总结
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 > nocturnal voids ≥2
- •NPI >0.33
排除标准
- •Polydipsia
- •Cardiac failure
- •Syndrome of inappropriate antidiuretic hormone secretion
- •Hyponatraemia
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •Moderate or severe over-active bladder (OAB)
- •Severe benign prostate hyperplasia (BPH)
- •Sleep apnoea
- •Interstitial cystitis
- •Stress urinary incontinence
- •Diabetes insipidus
- •Complication or a history of urological cancer
研究组 & 干预措施
SK-1404 low dose
Experimental
干预措施: SK-1404 (Drug)
SK-1404 high dose
Experimental
干预措施: SK-1404 (Drug)
SK-1404 middle dose
Experimental
干预措施: SK-1404 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in mean number of nocturnal voids
时间窗: 4 weeks
Assessed by the voiding diary
次要结局
- Change from base line in mean time to first awakening to void(4 weeks)
- Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)(4 weeks)
- Change from base line in mean nocturnal urine volume(4 weeks)
- Change from base line in mean Nocturnal Polyuria Index (NPI)(4 weeks)
研究者
研究点 (1)
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