Nocturia Due to Nocturnal Polyuria
Conditions
Keywords
Hyponatremia, Long-term treatment
Brief summary
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.
Interventions
DRUGDesmopressin
Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia | 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. |
| Occurrence of Hyponatremia | 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 | 1 year | — |
| Distribution of Serum Sodium Levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset Situation of Adverse Drug Reaction/Infectious Disease | 1 year | 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. |
| Onset Situation of Serious Adverse Events (SAEs) | Up to 1 year | 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. |
| Factors Affecting Safety | 1 year | 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. |
| Compliance with proper use of drug | 1 year | Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented. |
Countries
Japan
Outcome results
None listed