Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia) (NOC01)

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

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.

Study Overview

• Status: Completed
• Conditions: Nocturia Due to Nocturnal Polyuria
• Intervention / Treatment: Drug: Desmopressin

• Study Type: Observational
• Enrollment (Actual): 1087

Contacts and Locations

• Study Contact: Name: Global Clinical Compliance; Phone Number: +1 833-548-1402 (US/Canada); Email: DK0-Disclosure@ferring.com
• Study Contact Backup: Name: Global Clinical Compliance; Phone Number: +1 862-286-5200 (outside US); Email: DK0-Disclosure@ferring.com

Study Locations

• Japan
  • Tokyo, Japan
    • Survey Site (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Nocturia; Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice.	Drug: Desmopressin; Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.; Other Names: MINIRINMELT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Hyponatremia	Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.	1 year
Time to Onset of Hyponatremia		1 year
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Compliance with proper use of drug	Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented.	1 year

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2020
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hyponatremia; Long-term treatment
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nocturia; Polyuria; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 000346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No