A Study of Minirin Melt in Patients With Nocturia

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014