DRUG
Desmopressin
Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.
Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)
Status
Completed
Phase
Not applicable
Enrollment
1,087
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 1, 2020
Study start
May 19, 2020
Primary completion
Sep 25, 2024
Study completion
Sep 25, 2024
Results posted
Not reported
Registry updated
Dec 20, 2024
Outcomes
What the study measures.
Primary outcomes
Occurrence of Hyponatremia
Time frame · 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
Time frame · 1 year
Distribution of Serum Sodium Levels
Time frame · 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
Time frame · 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.
Secondary outcomes
Onset Situation of Adverse Drug Reaction/Infectious Disease
Time frame · 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)
Time frame · 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
Time frame · 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
Time frame · 1 year
Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- MALE
- 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 exclusion criteria defined for this study.
Study locations
1 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
Survey Site (there may be other sites in this country)
Tokyo, Japan
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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