A Multi-Centre Trial Investigating the Long Term Safety and Tolerability of Desmopressin (FE 992026) Orally Disintegrating Tablets for the Treatment of Nocturia Due to Nocturnal Polyuria in Japanese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- The frequency and severity of adverse events
研究概览
简要总结
Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year
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)
盲法说明
One dose level (25 μg desmopressin OCD) is included for female subjects and will be open-labelled for all female subjects.
Two different dose levels (25 μg desmopressin and 50 μg desmopressin ODT are included for male subjects in a double-blinded manner. Male subjects continuing from trial 000130 will continue their randomised treatment and subjects who received placebo will be randomised to one of the 2 dose levels (25 μg desmopressin or 50 μg desmopressin ODT).
New male subjects will be allocated to receive 50 μg desmopressin ODT in an open-labelled manner.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Desmopressin ODT 25 μg (male previous on 25 μg)
Subjects received 25 μg in trial 000130
干预措施: Desmopressin ODT 25 μg (Drug)
Desmopressin ODT 25 μg (female previous on 25 μg)
Subjects received 25 μg in trial 000129.
干预措施: Desmopressin ODT 25 μg (Drug)
Desmopressin ODT 25 μg (female previously on placebo)
Subjects received placebo in trial 000129
干预措施: Desmopressin ODT 25 μg (Drug)
Desmopressin ODT 25 μg (female)
New female subjects
干预措施: Desmopressin ODT 25 μg (Drug)
Desmopressin ODT 50 μg (male previous on 50 μg)
Subjects received 50 μg in trial 000130
干预措施: Desmopressin ODT 50 μg (Drug)
Desmopressin ODT 50 μg (male previous on placebo)
Subjects received placebo in trial 000130
干预措施: Desmopressin ODT 50 μg (Drug)
Desmopressin ODT 25 μg (male)
Subjects received placebo in trial 000130
干预措施: Desmopressin ODT 25 μg (Drug)
Desmopressin ODT 50 μg (male)
New male subjects
干预措施: Desmopressin ODT 50 μg (Drug)
结局指标
主要结局
The frequency and severity of adverse events
时间窗: Up to 1 year
During long-term treatment
Clinically significant changes in laboratory values and vital signs
时间窗: Up to 1 year
During long-term treatment
The incidence and severity of hyponatraemia
时间窗: Up to 1 year
Measured by serum sodium levels during long-term treatment
次要结局
- Change from baseline in mean number of nocturnal voids(Week 12, 24, 40 and 52)
- Change from baseline in mean time to first awakening to void(Week 12, 24, 40 and 52)
- Change from baseline in mean nocturnal urin volume(Week 12, 24, 40 and 52)
- Change from baseline in mean Nocturnal Polyuria Index (NPI)(Week 12, 24, 40 and 52)
- Change from baseline in Insomnia Severity Index (ISI)(Week 12, 24, 40 and 52)
- Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)(Week 12, 24, 40 and 52)
- Change from baseline in bother score(Week 12, 24, 40 and 52)