NocturiaNCT01222598
A Study of Minirin Melt in Patients With Nocturia
An observational study of Nocturia, run by Ferring Pharmaceuticals at 37 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
- 588 participants
- Where
- 37 sitesCzechia
- Study dates
- Sep 2008to Mar 2011
- 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
- patients suffering from 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
37 sites in 1 country.
37 sites in 1 country
Czechia37 sites
Private Ambulance
Blansko
Private Ambulance
Brno
Trauma Hospital in Brno
Brno
Urocentrum
Brno
Uromeda, s.r.o.
Brno
Private Ambulance
Brno-Zábrdovice
Private Ambulance
Bystřice pod Hostýnem
Hospital Dečín
Děčín
University Hospital Hradec Králové
Hradec Králové
Hospital Jablonec nad Nisou
Jablonec nad Nisou
Hospital Jihlava
Jihlava
Hospital Kroměříž
Kroměříž
Polyclinic Kuřim
Kuřim
Private Ambulance
Moravský Krumlov
Hospital Nové Město na Moravě
Nové Město na Moravě
Hospital with Polyclinic Nový Jičín
Nový Jičín
Private Ambulance
Nový Jičín
University Hospital Olomouc
Olomouc
City Hospital Ostrava
Ostrava
Hospital Ostrava
Ostrava
Private Ambulance
Ostrava
Central Military Hospital
Prague
Medicon, s.r.o.
Prague
Polyclinic Barandov
Prague
Private Ambulance
Prague
Railway Hospital
Prague
Thomayer´s Hospital
Prague
University Hospital Bulovka
Prague
Private Ambulance
Přerov
Hospital Prostějov
Prostějov
Hospital Šumperk
Šumperk
Private Ambulance
Třebíč
Hospital Uherské Hradiště
Uherské Hradiště
Hospital Ústí nad Orlicí, Inc
Ústí nad Orlicí
Hospital Valašské Meziříčí, Inc
Valašské Meziříčí
T. Bata Regional Hospital, Inc.
Zlín
Hospital Znojmo
Znojmo
About this study
Official title: Minirin Melt Tolerance With Nocturia in the Common Practice Conditions 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.
Number of participants with adverse events
Measured: 12 months
Secondary outcomes (2)
Number of participants with nocturnal voiding
Measured: 12 months
Number of participants with adverse events
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 posted18 Oct 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionMar 2011
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
- 588 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
- NCT01222598
- Sponsor's protocol ID
- FE992026 CS38
- Status last verified
- Oct 2012
- First submitted
- 5 Oct 2010
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minirin Melt Tolerance With Nocturia in the Common Practice Conditions in Czech Republic
- ClinicalTrials.gov ID
- NCT01222598
- Acronym / sponsor ID
- FE992026 CS38
- Conditions
- Nocturia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Oct 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)
- patients suffering from 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
Number of participants with adverse events
Time frame: 12 months
2 secondary outcomes
Number of participants with nocturnal voiding
Time frame: 12 months
Number of participants with adverse events
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 8 Oct 2012.
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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
37 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 37 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 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
Number of participants with adverse events (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 8 Oct 2012.