A Study of Minirin Melt in Patients With Nocturia - Full Text View

Purpose

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

Condition
Nocturia

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Verify the safety profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety aspect of dosage [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	2187
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212224

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Locations

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

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01212224 History of Changes
Other Study ID Numbers:	FE992026 CS37
Study First Received:	September 21, 2010
Last Updated:	May 13, 2013
Health Authority:	Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:

Nocturia
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013