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

Completed

• Conditions: Nocturia Due to Nocturnal Polyuria
• Interventions: Drug: Desmopressin

• Registration Number: NCT04329975
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-05-19
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1087

Inclusion Criteria

• Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.

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Exclusion Criteria

• No exclusion criteria defined for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Nocturia	Desmopressin	Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Survey Site (there may be other sites in this country); 🇯🇵 Tokyo, Japan