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Clinical trial

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

ID
Name
000346
Description
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.
Trial arms
Trial start
2020-05-19
Estimated PCD
2023-09-30
Trial end
2023-09-30
Status
Completed
Treatment
Desmopressin
Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.
Arms:
Participants with Nocturia
Other names:
MINIRINMELT
Size
1087
Primary endpoint
Occurrence of Hyponatremia
1 year
Time to Onset of Hyponatremia
1 year
Distribution of Serum Sodium Levels
1 year
Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia
1 year
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Year', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1087, 'type': 'ACTUAL'}}
Updated at
2023-10-25

1 organization

1 product

1 indication

Product
Desmopressin
Indication
Nocturnal Polyuria
Organization
Ferring Pharmaceuticals