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Completed

NCT Number: NCT04329975

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

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.

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Key information

Conditions

Nocturia Due to Nocturnal Polyuria Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Survey Site (there may be other sites in this country)

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desmopressin

Drug

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

Other names: MINIRINMELT

Primary outcomes

  1. Occurrence of Hyponatremia

    Time frame: 1 year

    Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.

  2. Time to Onset of Hyponatremia

    Time frame: 1 year

  3. Distribution of Serum Sodium Levels

    Time frame: 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.

  4. Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia

    Time frame: 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 outcomes

  1. Onset Situation of Adverse Drug Reaction/Infectious Disease

    Time frame: 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.

  2. Onset Situation of Serious Adverse Events (SAEs)

    Time frame: 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.

  3. Factors Affecting Safety

    Time frame: 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.

  4. Compliance with proper use of drug

    Time frame: 1 year

    Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: NOC01

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2020
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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