Nocturia Due to Nocturnal PolyuriaNOC01NCT04329975
Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)
An observational study of Nocturia Due to Nocturnal Polyuria, run by Ferring Pharmaceuticals at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Nocturia Due to Nocturnal Polyuria
- What is being tested?
- Desmopressin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,087 participants
- Where
- 1 siteJapan
- Study dates
- 19 May 2020to 25 Sep 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
Who may be able to join
- Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
Who cannot join
- No exclusion criteria defined for this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Nocturia Due to Nocturnal Polyuria
- Being tested
- Desmopressin
- Keywords
- Hyponatremia, Long-term treatment
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called MINIRINMELT
Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Nocturia | Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice. Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Hyponatremia
Hyponatremia will be confirmed by the investigator if the serum sodium value is 130 mmol/L or less.
Measured: 1 year
Time to Onset of Hyponatremia
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Compliance with proper use of drug
Number of participants with proper use of drug (MINIRINMELT 25 or 50 μg) will be presented.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start19 May 2020
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturia Due to Nocturnal PolyuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,087 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329975
- Sponsor's protocol ID
- 000346
- Acronym
- NOC01
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2020
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04329975
- Acronym / sponsor ID
- NOC01 / 000346
- Conditions
- Nocturia Due to Nocturnal Polyuria
- Keywords
- Hyponatremia, Long-term treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,087 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 May 2020 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Nocturia | – | Drug: DesmopressinParticipants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
Key inclusion criteria (1 listed)
- Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
Key exclusion criteria (1 listed)
- No exclusion criteria defined for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinAlso: MINIRINMELTDesmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally. | Drug | Participants with Nocturia |
Primary outcome
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.
Time to Onset of Hyponatremia
Time frame: 1 year
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.
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.
4 secondary outcomes
Onset Situation of Adverse Drug Reaction/Infectious Disease
Time frame: 1 year
Onset Situation of Serious Adverse Events (SAEs)
Time frame: Up to 1 year
Factors Affecting Safety
Time frame: 1 year
Compliance with proper use of drug
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturia Due to Nocturnal Polyuria, run by Ferring Pharmaceuticals at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Hyponatremia (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.