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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01222598
Other study ID # FE992026 CS38
Secondary ID
Status Completed
Phase N/A
First received October 5, 2010
Last updated October 5, 2012
Start date September 2008
Est. completion date March 2011

Study information

Verified date October 2012
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 588
Est. completion date March 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Czech Republic Hospital Šumperk Šumperk
Czech Republic Private Ambulance Blansko
Czech Republic Private Ambulance Brno
Czech Republic Trauma Hospital in Brno Brno
Czech Republic Urocentrum Brno
Czech Republic Uromeda, s.r.o. Brno
Czech Republic Private Ambulance Brno-Zábrdovice
Czech Republic Private Ambulance Bystrice pod Hostýnem
Czech Republic Hospital Decín Decín
Czech Republic University Hospital Hradec Králové Hradec Králové
Czech Republic Hospital Jablonec nad Nisou Jablonec nad Nisou
Czech Republic Hospital Jihlava Jihlava
Czech Republic Hospital Kromeríž Kromeríž
Czech Republic Polyclinic Kurim Kurim
Czech Republic Private Ambulance Moravský Krumlov
Czech Republic Hospital Nové Mesto na Morave Nové Mesto na Morave
Czech Republic Hospital with Polyclinic Nový Jicín Nový Jicín
Czech Republic Private Ambulance Nový Jicín
Czech Republic University Hospital Olomouc Olomouc
Czech Republic City Hospital Ostrava Ostrava
Czech Republic Hospital Ostrava Ostrava
Czech Republic Private Ambulance Ostrava
Czech Republic Central Military Hospital Prague
Czech Republic Medicon, s.r.o. Prague
Czech Republic Polyclinic Barandov Prague
Czech Republic Railway Hospital Prague
Czech Republic Thomayer´s Hospital Prague
Czech Republic University Hospital Bulovka Prague
Czech Republic Private Ambulance Prague 10
Czech Republic Private Ambulance Praha 4
Czech Republic Private Ambulance Prerov
Czech Republic Hospital Prostejov Prostejov
Czech Republic Private Ambulance Trebíc
Czech Republic Hospital Uherské Hradište Uherské Hradište
Czech Republic Hospital Ústí nad Orlicí, Inc Ústí nad Orlicí
Czech Republic Hospital Valašské Mezirící, Inc Valašské Mezirící
Czech Republic T. Bata Regional Hospital, Inc. Zlín
Czech Republic Hospital Znojmo Znojmo

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events 12 months Yes
Secondary Number of participants with nocturnal voiding 12 months No
Secondary Number of participants with adverse events 12 months Yes
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