Clinical trial NCT01222598: A Study of Minirin Melt in Patients With Nocturia
Official title: Minirin Melt Tolerance With Nocturia in the Common Practice Conditions in Czech Republic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 588
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:

* patients suffering from 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: Number of participants with adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with nocturnal voiding
timeFrame: 12 months
measure: Number of participants with adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Blansko
country: Czech Republic
facility: Private Ambulance
city: Brno-Zábrdovice
country: Czech Republic
facility: Private Ambulance
city: Brno
country: Czech Republic
facility: Private Ambulance
city: Brno
country: Czech Republic
facility: Trauma Hospital in Brno
city: Brno
country: Czech Republic
facility: Urocentrum
city: Brno
country: Czech Republic
facility: Uromeda, s.r.o.
city: Bystřice pod Hostýnem
country: Czech Republic
facility: Private Ambulance
city: Děčín
country: Czech Republic
facility: Hospital Dečín
city: Hradec Králové
country: Czech Republic
facility: University Hospital Hradec Králové
city: Jablonec nad Nisou
country: Czech Republic
facility: Hospital Jablonec nad Nisou
city: Jihlava
country: Czech Republic
facility: Hospital Jihlava
city: Kroměříž
country: Czech Republic
facility: Hospital Kroměříž
city: Kuřim
country: Czech Republic
facility: Polyclinic Kuřim
city: Moravský Krumlov
country: Czech Republic
facility: Private Ambulance
city: Nové Město na Moravě
country: Czech Republic
facility: Hospital Nové Město na Moravě
city: Nový Jičín
country: Czech Republic
facility: Hospital with Polyclinic Nový Jičín
city: Nový Jičín
country: Czech Republic
facility: Private Ambulance
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Ostrava
country: Czech Republic
facility: City Hospital Ostrava
city: Ostrava
country: Czech Republic
facility: Hospital Ostrava
city: Ostrava
country: Czech Republic
facility: Private Ambulance
city: Prague 10
country: Czech Republic
facility: Private Ambulance
city: Prague
country: Czech Republic
facility: Central Military Hospital
city: Prague
country: Czech Republic
facility: Medicon, s.r.o.
city: Prague
country: Czech Republic
facility: Polyclinic Barandov
city: Prague
country: Czech Republic
facility: Railway Hospital
city: Prague
country: Czech Republic
facility: Thomayer´s Hospital
city: Prague
country: Czech Republic
facility: University Hospital Bulovka
city: Praha 4
country: Czech Republic
facility: Private Ambulance
city: Prostějov
country: Czech Republic
facility: Hospital Prostějov
city: Přerov
country: Czech Republic
facility: Private Ambulance
city: Třebíč
country: Czech Republic
facility: Private Ambulance
city: Uherské Hradiště
country: Czech Republic
facility: Hospital Uherské Hradiště
city: Valašské Meziříčí
country: Czech Republic
facility: Hospital Valašské Meziříčí, Inc
city: Zlín
country: Czech Republic
facility: T. Bata Regional Hospital, Inc.
city: Znojmo
country: Czech Republic
facility: Hospital Znojmo
city: Ústí nad Orlicí
country: Czech Republic
facility: Hospital Ústí nad Orlicí, Inc
city: Šumperk
country: Czech Republic
facility: Hospital Šumperk
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: