A Study of Minirin Melt in Patients With Nocturia

Completed

• Conditions: Nocturia

• Registration Number: NCT01222598
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 588

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	12 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with nocturnal voiding	12 months
Number of participants with adverse events	12 months

Trial Locations

Locations (28)

Trauma Hospital in Brno; 🇨🇿 Brno, Czech Republic

Urocentrum; 🇨🇿 Brno, Czech Republic

Uromeda, s.r.o.; 🇨🇿 Brno, Czech Republic

Hospital Dečín; 🇨🇿 Děčín, Czech Republic

University Hospital Hradec Králové; 🇨🇿 Hradec Králové, Czech Republic

Hospital Jihlava; 🇨🇿 Jihlava, Czech Republic

Polyclinic Kuřim; 🇨🇿 Kuřim, Czech Republic

University Hospital Olomouc; 🇨🇿 Olomouc, Czech Republic

University Hospital Bulovka; 🇨🇿 Prague, Czech Republic

Hospital Uherské Hradiště; 🇨🇿 Uherské Hradiště, Czech Republic

T. Bata Regional Hospital, Inc.; 🇨🇿 Zlín, Czech Republic

Hospital Znojmo; 🇨🇿 Znojmo, Czech Republic

Hospital Ústí nad Orlicí, Inc; 🇨🇿 Ústí nad Orlicí, Czech Republic

Hospital Kroměříž; 🇨🇿 Kroměříž, Czech Republic

Hospital Nové Město na Moravě; 🇨🇿 Nové Město na Moravě, Czech Republic

Central Military Hospital; 🇨🇿 Prague, Czech Republic

Hospital with Polyclinic Nový Jičín; 🇨🇿 Nový Jičín, Czech Republic

City Hospital Ostrava; 🇨🇿 Ostrava, 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

Hospital Prostějov; 🇨🇿 Prostějov, Czech Republic

Hospital Šumperk; 🇨🇿 Šumperk, Czech Republic

Hospital Jablonec nad Nisou; 🇨🇿 Jablonec nad Nisou, Czech Republic

Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic

Hospital Valašské Meziříčí, Inc; 🇨🇿 Valašské Meziříčí, Czech Republic

Private Ambulance; 🇨🇿 Třebíč, Czech Republic