A Study of Minirin Melt in Patients With Nocturia
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01222598
First received: October 5, 2010
Last updated: October 5, 2012
Last verified: October 2012
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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: | Minirin Melt Tolerance With Nocturia in the Common Practice Conditions in Czech Republic |
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Number of participants with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of participants with nocturnal voiding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of participants with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 588 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222598
Locations
| Czech Republic | |
| Private Ambulance | |
| Blansko, Czech Republic | |
| Urocentrum | |
| Brno, Czech Republic | |
| Trauma Hospital in Brno | |
| Brno, Czech Republic | |
| Uromeda, s.r.o. | |
| Brno, Czech Republic | |
| Private Ambulance | |
| Brno, Czech Republic | |
| Private Ambulance | |
| Brno-Zábrdovice, Czech Republic | |
| Private Ambulance | |
| Bystřice pod Hostýnem, Czech Republic | |
| Hospital Dečín | |
| Děčín, 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 Kroměříž | |
| Kroměříž, Czech Republic | |
| Polyclinic Kuřim | |
| Kuřim, Czech Republic | |
| Private Ambulance | |
| Moravský Krumlov, Czech Republic | |
| Hospital Nové Město na Moravě | |
| Nové Město na Moravě, Czech Republic | |
| Private Ambulance | |
| Nový Jičín, Czech Republic | |
| Hospital with Polyclinic Nový Jičín | |
| Nový Jičín, Czech Republic | |
| University Hospital Olomouc | |
| Olomouc, Czech Republic | |
| Private Ambulance | |
| Ostrava, Czech Republic | |
| City Hospital Ostrava | |
| Ostrava, Czech Republic | |
| Hospital Ostrava | |
| Ostrava, Czech Republic | |
| Polyclinic Barandov | |
| Prague, Czech Republic | |
| Medicon, s.r.o. | |
| Prague, Czech Republic | |
| University Hospital Bulovka | |
| Prague, Czech Republic | |
| Central Military Hospital | |
| Prague, Czech Republic | |
| Thomayer´s Hospital | |
| Prague, Czech Republic | |
| Railway Hospital | |
| Prague, Czech Republic | |
| Private Ambulance | |
| Prague 10, Czech Republic | |
| Private Ambulance | |
| Praha 4, Czech Republic | |
| Hospital Prostějov | |
| Prostějov, Czech Republic | |
| Private Ambulance | |
| Přerov, Czech Republic | |
| Private Ambulance | |
| Třebíč, Czech Republic | |
| Hospital Uherské Hradiště | |
| Uherské Hradiště, Czech Republic | |
| Hospital Valašské Meziříčí, Inc | |
| Valašské Meziříčí, 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 Šumperk | |
| 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: | NCT01222598 History of Changes |
| Other Study ID Numbers: | FE992026 CS38 |
| Study First Received: | October 5, 2010 |
| Last Updated: | October 5, 2012 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Additional relevant MeSH terms:
|
Nocturia Urological Manifestations Signs and Symptoms Deamino Arginine Vasopressin Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013