Clinical trial NCT01212224: A Study of Minirin Melt in Patients With Nocturia
Official title: Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 2187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This is a confirmation of safety profile for Minirin Melt in clinical practice.


Eligibility criteria: Inclusion Criteria:

* nocturia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Verify the safety profile
timeFrame: 12 months
Secondary outcomes:
measure: Safety aspect of dosage
timeFrame: 12 months
Other outcomes:
Locations:
city: Benešov
country: Czech Republic
facility: Nemocnice Rudolfa a Stefanie
city: Benešov
country: Czech Republic
facility: Private ambulance Benešov
city: Beroun
country: Czech Republic
facility: Private ambulance Beroun
city: Bohumín
country: Czech Republic
facility: Private ambulance - Slezská urologie, s.r.o.
city: Brno - Zábrdovice
country: Czech Republic
facility: Private ambulance
city: Brno
country: Czech Republic
facility: Health centre Brno
city: Brno
country: Czech Republic
facility: Hospital Accident
city: Brno
country: Czech Republic
facility: Hospital Delta - private ambulance
city: Brno
country: Czech Republic
facility: Private ambulance Uro-Clinic, s.r.o.
city: Brno
country: Czech Republic
facility: Urocentrum
city: Domažlice
country: Czech Republic
facility: Domažlická nemocnice a.s.
city: Dvůr Králové
country: Czech Republic
facility: Soukromá ambulance Dvůr Králové
city: Děčín
country: Czech Republic
facility: Hospital Děčín
city: Hanušovice
country: Czech Republic
facility: Private ambulance
city: Havlíčkův Brod
country: Czech Republic
facility: Hospital Havlíčkův Brod
city: Havířov
country: Czech Republic
facility: Hospital with health centre
city: Hluk
country: Czech Republic
facility: Gynekologická ambulance Hluk
city: Horšovský Týn
country: Czech Republic
facility: Private ambulance Urologie, s.r.o.
city: Hradec Králové
country: Czech Republic
facility: Hospital Hradec Králové
city: Hustopeč u Brna
country: Czech Republic
facility: Městská nemocnice Hustopeče
city: Jablonec nad Nisou
country: Czech Republic
facility: Private ambulance
city: Jablonec nad Nisou
country: Czech Republic
facility: Soukromá ambulance Jablonec nad Nisou
city: Jilemnice
country: Czech Republic
facility: Private ambulance
city: Karlovy Vary
country: Czech Republic
facility: Hospital ambulance
city: Kladno
country: Czech Republic
facility: Oblastní nemocnice Kladno
city: Krnov
country: Czech Republic
facility: Hospital Krnov
city: Kromeriz
country: Czech Republic
facility: Hospital Kromeriz
city: Kuřim
country: Czech Republic
facility: Soukromá ambulance Kuřim
city: Lanškroun
country: Czech Republic
facility: Private ambulance
city: Mohelnice
country: Czech Republic
facility: Soukromá ambulance Mohelnice
city: Nový Jičín
country: Czech Republic
facility: Private ambulance
city: Náchod
country: Czech Republic
facility: Hospital Náchod
city: Olomouc
country: Czech Republic
facility: Hospital Olomouc
city: Olomouc
country: Czech Republic
facility: Private ambulance - Mediol, s.r.o.
city: Ostrava - Poruba
country: Czech Republic
facility: Private ambulance
city: Ostrava - Vítkovice
country: Czech Republic
facility: Vítkovická hospital
city: Ostrava
country: Czech Republic
facility: City Hospital
city: Pelhřimov
country: Czech Republic
facility: Hospital Pelhřimov
city: Plzeň
country: Czech Republic
facility: Hospital Plzeň
city: Plzeň
country: Czech Republic
facility: Private ambulance Plzeň
city: Prachatice
country: Czech Republic
facility: Private ambulance Prachatice
city: Praha 10
country: Czech Republic
facility: Private ambulance
city: Praha 2
country: Czech Republic
facility: Hospital Želeniční nemocnice
city: Praha 2
country: Czech Republic
facility: Urocentrum Praha 2
city: Praha 2
country: Czech Republic
facility: Urology clinic Hospital Praha
city: Praha 2
country: Czech Republic
facility: Všeobecná fakultní nemocnice
city: Praha 4
country: Czech Republic
facility: Medicon
city: Praha 4
country: Czech Republic
facility: Private ambulance - Urosante s.r.o.
city: Praha 4
country: Czech Republic
facility: Private ambulance Praha 4
city: Praha 4
country: Czech Republic
facility: Thomayer Hospital
city: Praha 5
country: Czech Republic
facility: Private ambulance Praha 5
city: Praha 5
country: Czech Republic
facility: Private ambulance
city: Praha 6
country: Czech Republic
facility: Urocare
city: Praha 7
country: Czech Republic
facility: Private ambulance
city: Praha 7
country: Czech Republic
facility: Private gyn. ambulance
city: Praha 8
country: Czech Republic
facility: Hospital Bulovka
city: Praha 8
country: Czech Republic
facility: Privátní ambulance Dr. A. Antončík
city: Písek
country: Czech Republic
facility: Hospital Písek
city: Přerov
country: Czech Republic
facility: Hospital Přerov
city: Přeštice
country: Czech Republic
facility: Private ambulance - Preštice
city: Rakovník
country: Czech Republic
facility: Private ambulance
city: Roudnice nad Labem
country: Czech Republic
facility: Soukromá ambulance Roudnice nad Labem
city: Rožnov pod Radhoštěm
country: Czech Republic
facility: Private ambulance
city: Teplice
country: Czech Republic
facility: Hospital ambulance
city: Turnov
country: Czech Republic
facility: Panoch Hospital
city: Tábor
country: Czech Republic
facility: Hospital Tábor
city: Třebíč
country: Czech Republic
facility: Hospital Třebíč
city: Třinec
country: Czech Republic
facility: Hospital Podlesí,s.r.o.
city: Uherské Hradiště
country: Czech Republic
facility: Hospital with health centre
city: Valašské Meziřící
country: Czech Republic
facility: Nemocnice Valašské Meziříčí
city: Zlin
country: Czech Republic
facility: Private ambulance
city: Zlín
country: Czech Republic
facility: Krajská nemocnice T. Bati
city: Zlín
country: Czech Republic
facility: Medel, s.r.o.
city: Zlín
country: Czech Republic
facility: Private ambulance Lékařský dům
city: Znojmo
country: Czech Republic
facility: UROKAN, s.r.o.
city: Ústí nad Labem
country: Czech Republic
facility: Masaryk Hospital
city: Ústí nad Orlicí
country: Czech Republic
facility: Hospital Ústí nad Orlicí
city: Černošice
country: Czech Republic
facility: Soukromá ambulanc Černošice
city: Česká Lípa
country: Czech Republic
facility: Hospital Česká Lípa
city: Říčany
country: Czech Republic
facility: Hospital Řičany - private ambulance
city: Štenberk
country: Czech Republic
facility: Soukromá ambulance Štenberk
city: Šumperk
country: Czech Republic
facility: Private ambulance
city: Šumperk
country: Czech Republic
facility: Šumperská nemocnice
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: