Nocturia Clinical Trial
Official title:
A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic
| Verified date | May 2016 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Czech Republic: State Institute for Drug Control |
| Study type | Observational |
A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice
| Status | Completed |
| Enrollment | 4136 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - nocturia Exclusion Criteria: - habitual or psychogenic polydipsia, - known or suspected cardiac insufficiency - other conditions requiring treatment with diuretics - moderate and severe renal insufficiency - known hyponatremia - syndrome of inappropriate ADH secretion |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Soukromá ambulance Štemberk | Štemberk | |
| Czech Republic | Nemocnice Rudolfa a Stefanie (there may be other sites in this country) | Benešov | |
| Czech Republic | Soukromá ambulance, Benešov | Benešov | |
| Czech Republic | Soukromá ambulance Beroun | Beroun | |
| Czech Republic | Slezská urologie | Bohunín | |
| Czech Republic | Úrazová nemocnice Brno | Brno | |
| Czech Republic | URIONTEGRITAS soukromá ambulance | Brno | |
| Czech Republic | Uro - clinic | Brno | |
| Czech Republic | Urocentrum Brno | Brno | |
| Czech Republic | Soukromá ambalance | Citonice | |
| Czech Republic | Domažlická Nemocnice | Domažlice | |
| Czech Republic | Mestská nemocnice Dvur Králové nad Labem a.s. | Dvur Králové nad Labem | |
| Czech Republic | Nemocnice s poliklinkou Havírov | Havírov | |
| Czech Republic | Nemocnice Havlíckuv Brod | Havlíckuv Brod | |
| Czech Republic | Gynekologická ambulance Hluk | Hluk | |
| Czech Republic | Fakultní nemocnice Hradec Králové | Hradec Králové | |
| Czech Republic | PPCHC Sanus Hradec Králové | Hradec Králové | |
| Czech Republic | Mestská nemocnice Hustopece | Hustopece u Brna | |
| Czech Republic | Urologická ambulance UROLA | Jaromer | |
| Czech Republic | Soukromá ambulance, Jilemnice | Jilemnice | |
| Czech Republic | Oblastní nemocnice Kladno a.s. | Kladno | |
| Czech Republic | Urologie s.r.o. | Klatovy | |
| Czech Republic | Soukromá ambulance Krnov | Krnov | |
| Czech Republic | Kromerizska nemocnice a.s. | Kromeriz | |
| Czech Republic | Soukromá ambulance, Lanškroun | Lanškroun | |
| Czech Republic | Soukromá ambulance Mohelnice | Mohelnice | |
| Czech Republic | Oblastní nemocnice Náchod | Náchod | |
| Czech Republic | Sourkomá ambulance, Nový Jicín | Nový Jicín | |
| Czech Republic | Nemocnice Nový Jicín | Nový Jícín | |
| Czech Republic | Centrum MEDIOL s.r.o. | Olomouc | |
| Czech Republic | FN Olomouc | Olomouc | |
| Czech Republic | Mestská nemocnice Ostrava | Ostrava | |
| Czech Republic | Gynekologická ambulance | Ostrava Ploskovice | |
| Czech Republic | Vítkovická Nemocnice a.s. | Ostrava-Vítkovice | |
| Czech Republic | Nemocnice Pelhrimov | Pelhrimov | |
| Czech Republic | Nemocnice Písek | Písek | |
| Czech Republic | FN Plzen | Plzen | |
| Czech Republic | Poliklinika Denisovo nábreží | Plzen | |
| Czech Republic | Urologická ambulance | Prachatice | |
| Czech Republic | Urologická klinika Praha 1 | Praha 1 | |
| Czech Republic | Urologie Zahradní Mesto s.r.o. | Praha 10 | |
| Czech Republic | Urologie - NZZ Lékarský dum | Praha 10 - Uhríneves | |
| Czech Republic | Nemocnice s poliklinikou Praha Italská | Praha 2 | |
| Czech Republic | VFN | Praha 2 | |
| Czech Republic | Medicon | Praha 4 | |
| Czech Republic | Urologické oddelení | Praha 4 | |
| Czech Republic | Soukromá ambulance, Praha 5 | Praha 5 | |
| Czech Republic | Urocare | Praha 6 | |
| Czech Republic | Ústrední vojenská nemocnice | Praha 6 | |
| Czech Republic | Soukromá ambulance Praha 7 | Praha 7 | |
| Czech Republic | FN Bulovka | Praha 8 | |
| Czech Republic | Urosanté s.r.o | Praha 8 | |
| Czech Republic | Soukromá ambulance, Preštice | Preštice | |
| Czech Republic | JR Urocentrum Prerov s.r.o. | Prerov | |
| Czech Republic | Urocare s.r.o. | Rícany | |
| Czech Republic | Nemocnice Tábor | Tábor | |
| Czech Republic | Krajská zdravotní - nemocnice Teplice | Teplice | |
| Czech Republic | Nemocnice Trebíc | Trebíc | |
| Czech Republic | Nemocnice Podlesí a.s. | Trinec | |
| Czech Republic | Urologická ambulance | Trutnov | |
| Czech Republic | Mestská nemocnice Turnov | Turnov | |
| Czech Republic | Nemocnice Uherské Hradište | Uherské Hradište | |
| Czech Republic | Masarykova nemocnice v Ústí nad Labem | Ústí nad Labem | |
| Czech Republic | Nemocnice Valašské Mezirící | Valašské Mezirící | |
| Czech Republic | DUAM s.r.o. Lékarský dum | Zlín | |
| Czech Republic | Krajská nemocnice T.Bati a.s. | Zlín | |
| Czech Republic | Soukromá ambulance, Zlín | Zlín | |
| Czech Republic | UROKAN s.r.o. | Znojmo |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with adverse events | 24 months | Yes | |
| Secondary | Number of changes in dosage regime | 24 months | No |
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