Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)

Study Overview
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Brief Summary
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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.

Official Title
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Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet 25μg / 50μg in Treatment for Male Nocturia Due to Nocturnal Polyuria

Conditions
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Nocturia Due to Nocturnal Polyuria

Intervention / Treatment
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* Drug: Desmopressin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug. Exclusion Criteria: No exclusion criteria defined for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Nocturia<br>Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice. | Drug: Desmopressin<br>* Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.<br>* Other names: MINIRINMELT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Hyponatremia | Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less. | 1 year | 
| Time to Onset of Hyponatremia |  | 1 year | 
| Distribution of Serum Sodium Levels | 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. | 1 year | 
| Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset Situation of Adverse Drug Reaction/Infectious Disease | An adverse event (AE) is any untoward medical occurrence that did not necessarily have a causal relationship with MINIRINMELT 25 or 50 μg. An ADR is an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the MINIRINMELT 25 or 50 μg. | 1 year | 
| Onset Situation of Serious Adverse Events (SAEs) | A SAE is any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the participant's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. | Up to 1 year | 
| Factors Affecting Safety | To evaluate the role of the following factors in the study: adverse drug reactions 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. | 1 year | 
| Compliance with proper use of drug | Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyponatremia, Long-term treatment