AzTrials
AzTrials

NocturiaNCT01552395

A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

An observational study of Nocturia, run by Ferring Pharmaceuticals at 68 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nocturia
How many people
4,136 participants
Where
68 sitesCzechia
Study dates
Mar 2012to Apr 2016
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult Patients Suffering From Nocturia 1x or More Times a Night

Who may be able to join

  • nocturia

Who cannot join

  • habitual or psychogenic polydipsia,
  • known or suspected cardiac insufficiency
  • other conditions requiring treatment with diuretics
  • moderate and severe renal insufficiency
  • known hyponatremia
  • syndrome of inappropriate ADH secretion

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

Czechia68 sites

  • Nemocnice Rudolfa a Stefanie (there may be other sites in this country)

    Benešov

  • Soukromá ambulance, Benešov

    Benešov

  • Soukromá ambulance Beroun

    Beroun

  • Slezská urologie

    Bohunín

  • URIONTEGRITAS soukromá ambulance

    Brno

  • Uro - clinic

    Brno

  • Urocentrum Brno

    Brno

  • Úrazová nemocnice Brno

    Brno

  • Soukromá ambalance

    Citonice

  • Domažlická Nemocnice

    Domažlice

  • Městská nemocnice Dvůr Králové nad Labem a.s.

    Dvůr Králové nad Labem

  • Nemocnice s poliklinkou Havířov

    Havířov

  • Nemocnice Havlíčkův Brod

    Havlíčkův Brod

  • Gynekologická ambulance Hluk

    Hluk

  • Fakultní nemocnice Hradec Králové

    Hradec Králové

  • PPCHC Sanus Hradec Králové

    Hradec Králové

  • Městská nemocnice Hustopeče

    Hustopeče U Brna

  • Urologická ambulance UROLA

    Jaroměř

  • Soukromá ambulance, Jilemnice

    Jilemnice

  • Oblastní nemocnice Kladno a.s.

    Kladno

  • Urologie s.r.o.

    Klatovy

  • Soukromá ambulance Krnov

    Krnov

  • Kromerizska nemocnice a.s.

    Kroměříž

  • Soukromá ambulance, Lanškroun

    Lanškroun

  • Soukromá ambulance Mohelnice

    Mohelnice

  • Oblastní nemocnice Náchod

    Náchod

  • Sourkomá ambulance, Nový Jičín

    Nový Jičín

  • Nemocnice Nový Jičín

    Nový Jíčín

  • Centrum MEDIOL s.r.o.

    Olomouc

  • FN Olomouc

    Olomouc

  • Městská nemocnice Ostrava

    Ostrava

  • Gynekologická ambulance

    Ostrava Ploskovice

  • Vítkovická Nemocnice a.s.

    Ostrava-Vítkovice

  • Nemocnice Pelhřimov

    Pelhřimov

  • FN Plzeň

    Pilsen

  • Poliklinika Denisovo nábřeží

    Pilsen

  • Nemocnice Písek

    Písek

  • Urologická ambulance

    Prachatice

  • FN Bulovka

    Prague

  • Medicon

    Prague

  • Nemocnice s poliklinikou Praha Italská

    Prague

  • Soukromá ambulance Praha 7

    Prague

  • Soukromá ambulance, Praha 5

    Prague

  • Urocare

    Prague

  • Urologická klinika Praha 1

    Prague

  • Urologické oddělení

    Prague

  • Urologie Zahradní Město s.r.o.

    Prague

  • Urosanté s.r.o

    Prague

  • VFN

    Prague

  • Ústřední vojenská nemocnice

    Prague

  • Urologie - NZZ Lékařský dům

    Praha 10 - Uhříněves

  • JR Urocentrum Přerov s.r.o.

    Přerov

  • Soukromá ambulance, Přeštice

    Přeštice

  • Urocare s.r.o.

    Říčany

  • Soukromá ambulance Štemberk

    Štemberk

  • Nemocnice Tábor

    Tábor

  • Krajská zdravotní - nemocnice Teplice

    Teplice

  • Nemocnice Třebíč

    Třebíč

  • Nemocnice Podlesí a.s.

    Třinec

  • Urologická ambulance

    Trutnov

  • Městská nemocnice Turnov

    Turnov

  • Nemocnice Uherské Hradiště

    Uherské Hradiště

  • Masarykova nemocnice v Ústí nad Labem

    Ústí nad Labem

  • Nemocnice Valašské Meziříčí

    Valašské Meziříčí

  • DUAM s.r.o. Lékařský dům

    Zlín

  • Krajská nemocnice T.Bati a.s.

    Zlín

  • Soukromá ambulance, Zlín

    Zlín

  • UROKAN s.r.o.

    Znojmo

Other trials in Czechia

About this study

Official title: A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic

A Confirmation of the 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.

  1. Number of patients with adverse events

    Measured: 24 months

Secondary outcomes (1)

  1. Number of changes in dosage regime

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
Prospective
Enrolment
4,136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01552395
Sponsor's protocol ID
000056
Status last verified
May 2016
First submitted
7 Mar 2012
Last updated
24 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Nocturia, run by Ferring Pharmaceuticals at 68 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 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: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 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 patients with adverse events (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01552395.

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 24 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in