NocturiaNCT01212224
A Study of Minirin Melt in Patients With Nocturia
An observational study of Nocturia, run by Ferring Pharmaceuticals at 81 sites in Czechia.
Trial summary
This is a confirmation of safety profile for Minirin Melt in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Nocturia
- How many people
- 2,187 participants
- Where
- 81 sitesCzechia
- Study dates
- Jan 2010to Dec 2013
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: primary care clinic
Who may be able to join
- nocturia
Who cannot join
- habitual or psychogenic polydipsia
- known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics
- moderate and severe renal insufficiency
- know hyponatremia
- syndrome of inappropriate ADH secretion
Trial locations and contacts
81 sites in 1 country.
81 sites in 1 country
Czechia81 sites
Nemocnice Rudolfa a Stefanie
Benešov
Private ambulance Benešov
Benešov
Private ambulance Beroun
Beroun
Private ambulance - Slezská urologie, s.r.o.
Bohumín
Health centre Brno
Brno
Hospital Accident
Brno
Hospital Delta - private ambulance
Brno
Private ambulance Uro-Clinic, s.r.o.
Brno
Urocentrum
Brno
Private ambulance
Brno - Zábrdovice
Soukromá ambulanc Černošice
Černošice
Hospital Česká Lípa
Česká Lípa
Hospital Děčín
Děčín
Domažlická nemocnice a.s.
Domažlice
Soukromá ambulance Dvůr Králové
Dvůr Králové
Private ambulance
Hanušovice
Hospital with health centre
Havířov
Hospital Havlíčkův Brod
Havlíčkův Brod
Gynekologická ambulance Hluk
Hluk
Private ambulance Urologie, s.r.o.
Horšovský Týn
Hospital Hradec Králové
Hradec Králové
Městská nemocnice Hustopeče
Hustopeč U Brna
Private ambulance
Jablonec nad Nisou
Soukromá ambulance Jablonec nad Nisou
Jablonec nad Nisou
Private ambulance
Jilemnice
Hospital ambulance
Karlovy Vary
Oblastní nemocnice Kladno
Kladno
Hospital Krnov
Krnov
Hospital Kromeriz
Kroměříž
Soukromá ambulance Kuřim
Kuřim
Private ambulance
Lanškroun
Soukromá ambulance Mohelnice
Mohelnice
Hospital Náchod
Náchod
Private ambulance
Nový Jičín
Hospital Olomouc
Olomouc
Private ambulance - Mediol, s.r.o.
Olomouc
City Hospital
Ostrava
Private ambulance
Ostrava - Poruba
Vítkovická hospital
Ostrava - Vítkovice
Hospital Pelhřimov
Pelhřimov
Hospital Plzeň
Pilsen
Private ambulance Plzeň
Pilsen
Hospital Písek
Písek
Private ambulance Prachatice
Prachatice
Hospital Bulovka
Prague
Hospital Želeniční nemocnice
Prague
Medicon
Prague
Private ambulance - Urosante s.r.o.
Prague
Private ambulance Praha 4
Prague
Private ambulance Praha 5
Prague
Private ambulance
Prague
Private gyn. ambulance
Prague
Privátní ambulance Dr. A. Antončík
Prague
Thomayer Hospital
Prague
Urocare
Prague
Urocentrum Praha 2
Prague
Urology clinic Hospital Praha
Prague
Všeobecná fakultní nemocnice
Prague
Hospital Přerov
Přerov
Private ambulance - Preštice
Přeštice
Private ambulance
Rakovník
Hospital Řičany - private ambulance
Říčany
Soukromá ambulance Roudnice nad Labem
Roudnice nad Labem
Private ambulance
Rožnov pod Radhoštěm
Soukromá ambulance Štenberk
Štenberk
Private ambulance
Šumperk
Šumperská nemocnice
Šumperk
Hospital Tábor
Tábor
Hospital ambulance
Teplice
Hospital Třebíč
Třebíč
Hospital Podlesí,s.r.o.
Třinec
Panoch Hospital
Turnov
Hospital with health centre
Uherské Hradiště
Masaryk Hospital
Ústí nad Labem
Hospital Ústí nad Orlicí
Ústí nad Orlicí
Nemocnice Valašské Meziříčí
Valašské Meziřící
Krajská nemocnice T. Bati
Zlín
Medel, s.r.o.
Zlín
Private ambulance Lékařský dům
Zlín
Private ambulance
Zlín
UROKAN, s.r.o.
Znojmo
About this study
Official title: Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic
This is a confirmation of safety profile for Minirin Melt in clinical practice.
- Conditions
- Nocturia
- Medical subject headings
- Nocturia
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the safety profile
Measured: 12 months
Secondary outcomes (1)
Safety aspect of dosage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2013
- Study completionDec 2013
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
- Time perspective
- Retrospective
- Enrolment
- 2,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212224
- Sponsor's protocol ID
- FE992026 CS37
- Status last verified
- Jan 2014
- First submitted
- 21 Sep 2010
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic
- ClinicalTrials.gov ID
- NCT01212224
- Acronym / sponsor ID
- FE992026 CS37
- Conditions
- Nocturia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,187 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Sep 2010 (estimated)
- 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.
This is a confirmation of safety profile for Minirin Melt in clinical practice.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- nocturia
Key exclusion criteria (5 listed)
- habitual or psychogenic polydipsia
- known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics
- moderate and severe renal insufficiency
- know hyponatremia
- syndrome of inappropriate ADH secretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Verify the safety profile
Time frame: 12 months
1 secondary outcome
Safety aspect of dosage
Time frame: 12 months
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 6 Jan 2014.
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An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
81 sites 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 81 sites in Czechia.
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 5 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 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in Czechia. 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?
Verify the safety profile (time frame: 12 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 6 Jan 2014.