CompletedNot Applicable

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

Japan1,087 participantsStarted 2020-05-19

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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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.

What they're measuring

Occurrence of Hyponatremia

Timeframe: 1 year

Time to Onset of Hyponatremia

Timeframe: 1 year

Distribution of Serum Sodium Levels

Timeframe: 1 year

Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia

Timeframe: 1 year

Trial details

NCT IDNCT04329975

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09-25

View on ClinicalTrials.gov More Nocturia Due to Nocturnal Polyuria trials