Clinical trial NCT01552395: A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia
Official title: A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 4136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients Suffering From Nocturia 1x or More Times a Night

Brief summary: A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice


Eligibility criteria: Inclusion Criteria:

* nocturia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Number of changes in dosage regime
timeFrame: 24 months
Other outcomes:
Locations:
city: Benešov
country: Czech Republic
facility: Nemocnice Rudolfa a Stefanie (there may be other sites in this country)
city: Benešov
country: Czech Republic
facility: Soukromá ambulance, Benešov
city: Beroun
country: Czech Republic
facility: Soukromá ambulance Beroun
city: Bohunín
country: Czech Republic
facility: Slezská urologie
city: Brno
country: Czech Republic
facility: URIONTEGRITAS soukromá ambulance
city: Brno
country: Czech Republic
facility: Uro - clinic
city: Brno
country: Czech Republic
facility: Urocentrum Brno
city: Brno
country: Czech Republic
facility: Úrazová nemocnice Brno
city: Citonice
country: Czech Republic
facility: Soukromá ambalance
city: Domažlice
country: Czech Republic
facility: Domažlická Nemocnice
city: Dvůr Králové nad Labem
country: Czech Republic
facility: Městská nemocnice Dvůr Králové nad Labem a.s.
city: Havlíčkův Brod
country: Czech Republic
facility: Nemocnice Havlíčkův Brod
city: Havířov
country: Czech Republic
facility: Nemocnice s poliklinkou Havířov
city: Hluk
country: Czech Republic
facility: Gynekologická ambulance Hluk
city: Hradec Králové
country: Czech Republic
facility: Fakultní nemocnice Hradec Králové
city: Hradec Králové
country: Czech Republic
facility: PPCHC Sanus Hradec Králové
city: Hustopeče u Brna
country: Czech Republic
facility: Městská nemocnice Hustopeče
city: Jaroměř
country: Czech Republic
facility: Urologická ambulance UROLA
city: Jilemnice
country: Czech Republic
facility: Soukromá ambulance, Jilemnice
city: Kladno
country: Czech Republic
facility: Oblastní nemocnice Kladno a.s.
city: Klatovy
country: Czech Republic
facility: Urologie s.r.o.
city: Krnov
country: Czech Republic
facility: Soukromá ambulance Krnov
city: Kromeriz
country: Czech Republic
facility: Kromerizska nemocnice a.s.
city: Lanškroun
country: Czech Republic
facility: Soukromá ambulance, Lanškroun
city: Mohelnice
country: Czech Republic
facility: Soukromá ambulance Mohelnice
city: Nový Jičín
country: Czech Republic
facility: Sourkomá ambulance, Nový Jičín
city: Nový Jíčín
country: Czech Republic
facility: Nemocnice Nový Jičín
city: Náchod
country: Czech Republic
facility: Oblastní nemocnice Náchod
city: Olomouc
country: Czech Republic
facility: Centrum MEDIOL s.r.o.
city: Olomouc
country: Czech Republic
facility: FN Olomouc
city: Ostrava Ploskovice
country: Czech Republic
facility: Gynekologická ambulance
city: Ostrava-Vítkovice
country: Czech Republic
facility: Vítkovická Nemocnice a.s.
city: Ostrava
country: Czech Republic
facility: Městská nemocnice Ostrava
city: Pelhřimov
country: Czech Republic
facility: Nemocnice Pelhřimov
city: Plzeň
country: Czech Republic
facility: FN Plzeň
city: Plzeň
country: Czech Republic
facility: Poliklinika Denisovo nábřeží
city: Prachatice
country: Czech Republic
facility: Urologická ambulance
city: Praha 10 - Uhříněves
country: Czech Republic
facility: Urologie - NZZ Lékařský dům
city: Praha 10
country: Czech Republic
facility: Urologie Zahradní Město s.r.o.
city: Praha 1
country: Czech Republic
facility: Urologická klinika Praha 1
city: Praha 2
country: Czech Republic
facility: Nemocnice s poliklinikou Praha Italská
city: Praha 2
country: Czech Republic
facility: VFN
city: Praha 4
country: Czech Republic
facility: Medicon
city: Praha 4
country: Czech Republic
facility: Urologické oddělení
city: Praha 5
country: Czech Republic
facility: Soukromá ambulance, Praha 5
city: Praha 6
country: Czech Republic
facility: Urocare
city: Praha 6
country: Czech Republic
facility: Ústřední vojenská nemocnice
city: Praha 7
country: Czech Republic
facility: Soukromá ambulance Praha 7
city: Praha 8
country: Czech Republic
facility: FN Bulovka
city: Praha 8
country: Czech Republic
facility: Urosanté s.r.o
city: Písek
country: Czech Republic
facility: Nemocnice Písek
city: Přerov
country: Czech Republic
facility: JR Urocentrum Přerov s.r.o.
city: Přeštice
country: Czech Republic
facility: Soukromá ambulance, Přeštice
city: Teplice
country: Czech Republic
facility: Krajská zdravotní - nemocnice Teplice
city: Trutnov
country: Czech Republic
facility: Urologická ambulance
city: Turnov
country: Czech Republic
facility: Městská nemocnice Turnov
city: Tábor
country: Czech Republic
facility: Nemocnice Tábor
city: Třebíč
country: Czech Republic
facility: Nemocnice Třebíč
city: Třinec
country: Czech Republic
facility: Nemocnice Podlesí a.s.
city: Uherské Hradiště
country: Czech Republic
facility: Nemocnice Uherské Hradiště
city: Valašské Meziříčí
country: Czech Republic
facility: Nemocnice Valašské Meziříčí
city: Zlín
country: Czech Republic
facility: DUAM s.r.o. Lékařský dům
city: Zlín
country: Czech Republic
facility: Krajská nemocnice T.Bati a.s.
city: Zlín
country: Czech Republic
facility: Soukromá ambulance, Zlín
city: Znojmo
country: Czech Republic
facility: UROKAN s.r.o.
city: Ústí nad Labem
country: Czech Republic
facility: Masarykova nemocnice v Ústí nad Labem
city: Říčany
country: Czech Republic
facility: Urocare s.r.o.
city: Štemberk
country: Czech Republic
facility: Soukromá ambulance Štemberk
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: