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

Nocturia Due to Nocturnal Polyuria Clinical Trial

— NOC01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329975
• Other study ID #: 000346
• Status: Completed
• Start date: May 19, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1087
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nocturia
• Nocturia Due to Nocturnal Polyuria
• Polyuria

Intervention

Drug:
• Desmopressin
Desmopressin (MINIRINMELT OD tablet) 25µg or 50µg, orally.

Locations

Country	Name	City	State
Japan	Survey Site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Hyponatremia	Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.	1 year
Primary	Time to Onset of Hyponatremia		1 year
Primary	Distribution of Serum Sodium Levels	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.	1 year
Primary	Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia	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.	1 year
Secondary	Onset Situation of Adverse Drug Reaction/Infectious Disease	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.	1 year
Secondary	Onset Situation of Serious Adverse Events (SAEs)	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.	Up to 1 year
Secondary	Factors Affecting Safety	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.	1 year
Secondary	Compliance with proper use of drug	Number of participants with proper use of drug (MINIRINMELT 25 or 50 µg) will be presented.	1 year