Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet 25μg / 50μg in Treatment for Male Nocturia Due to Nocturnal Polyuria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,087
- 试验地点
- 1
- 主要终点
- Occurrence of Hyponatremia
研究概览
简要总结
To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year [52 weeks]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal polyuria in men in daily clinical practice, and to confirm the compliance with proper use of this drug in clinical practice and to investigate the effectiveness of risk minimization activities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
排除标准
- •No exclusion criteria defined for this study.
研究组 & 干预措施
Participants with Nocturia
Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice.
干预措施: Desmopressin (Drug)
结局指标
主要结局
Occurrence of Hyponatremia
时间窗: 1 year
Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.
Time to Onset of Hyponatremia
时间窗: 1 year
Distribution of Serum Sodium Levels
时间窗: 1 year
Number of participants with mild decrease (serum sodium 134-130 mmol/L); moderate decrease (serum sodium \<130 mmol/L) and severe decrease (serum sodium \<=125 mmol/L) in serum sodium levels will be presented.
Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia
时间窗: 1 year
To evaluate the role of the following factors in the study: adverse drug reactions (ADRs) incidence rate by background factors such as dose of MINIRINMELT 25 or 50 μg, participant age, baseline serum sodium levels, kidney function according to creatinine clearance, medical history and concomitant medications.
次要结局
- Onset Situation of Adverse Drug Reaction/Infectious Disease(1 year)
- Onset Situation of Serious Adverse Events (SAEs)(Up to 1 year)
- Factors Affecting Safety(1 year)
- Compliance with proper use of drug(1 year)