An observational study in Nocturia Due to Nocturnal Polyuria, sponsored by Ferring Pharmaceuticals. Completed at 1 site in Japan. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Ferring Pharmaceuticals · Observational
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.
164 studies on the registry are indexed under Hyponatremia; 16 are open to participants now.
This study's enrollment of 1,087 is above the median of 200 across 61 observational studies indexed under Hyponatremia.
Browse Hyponatremia studies →Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: MINIRINMELT
Occurrence of Hyponatremia
Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.
Time frame: 1 year
Time to Onset of Hyponatremia
Time frame: 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.
Time frame: 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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Compliance with proper use of drug
Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.