NocturiaNCT03089073
Study of Minirin Melt® in Adult Patients With Nocturia
An observational study of Nocturia, run by Ferring Pharmaceuticals at 1 site in South Korea.
Trial summary
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin
- How many people
- 835 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2015to 5 Oct 2018
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients to whom Minirin melt is prescribed as regular treatment is included in accordance with their usual practice and consistent with Korean prescribing information for Minirin melt.
Who may be able to join
- Adult aged between 19 and 65 years
- Patients having nocturia
- Decision made to prescribe Minirin Melt according to prescription information
- Willingness and ability to provide written informed consent
Who cannot join
- When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)
- When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis
- When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)
- When patients have known hyponatremia
- When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
- When patients have hypersensitivity to the active substances or to any of the excipients
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daegu Fatima Hospital (there may be other sites in this country)
Daegu
About this study
Official title: Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia
- Conditions
- Nocturia
- Being tested
- Desmopressin
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin Melt®
60μg or 120μg once daily at bedtime
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of nocturnal voids
Calculated by 72 hour frequency volume chart (FVC)
Measured: Baseline and treatment-related visits up to 3 months
Secondary outcomes (1)
Reduction from baseline in the mean number of nocturnal voids
Assessed as a (50% decrease) or reduction of nocturnal diuresis (>20%)
Measured: Baseline and treatment-related visits up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start13 Jul 2015
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: Enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 835 participants (actual)
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
- NCT03089073
- Sponsor's protocol ID
- 000208
- Status last verified
- Feb 2021
- First submitted
- 20 Mar 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia
- ClinicalTrials.gov ID
- NCT03089073
- Acronym / sponsor ID
- 000208
- Conditions
- Nocturia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment challenges
- Enrolment
- 835 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 24 Mar 2017 (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.
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients to whom Minirin melt is prescribed as regular treatment is included in accordance with their usual practice and consistent with Korean prescribing information for Minirin melt.
Key inclusion criteria (4 listed)
- Adult aged between 19 and 65 years
- Patients having nocturia
- Decision made to prescribe Minirin Melt according to prescription information
- Willingness and ability to provide written informed consent
Key exclusion criteria (6 listed)
- When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)
- When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis
- When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)
- When patients have known hyponatremia
- When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
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: Minirin Melt®60μg or 120μg once daily at bedtime | Drug | – |
Primary outcome
Change from baseline in mean number of nocturnal voids
Time frame: Baseline and treatment-related visits up to 3 months
Calculated by 72 hour frequency volume chart (FVC)
1 secondary outcome
Reduction from baseline in the mean number of nocturnal voids
Time frame: Baseline and treatment-related visits up to 3 months
Results and safety
The study was stopped early (reason given: Enrollment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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, run by Ferring Pharmaceuticals at 1 site in South Korea.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Feb 2021. 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 South Korea. 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 was stopped early (reason given: Enrollment challenges). Results are not available in the source record.
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?
Change from baseline in mean number of nocturnal voids (time frame: Baseline and treatment-related visits up to 3 months). 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 5 Feb 2021.