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A Study of Minirin Melt in Patients With Nocturia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01222598
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a confirmation of safety profile for Minirin Melt in clinical practice.

Condition or disease
Nocturia

Study Design

Study Type : Observational
Actual Enrollment : 588 participants
Time Perspective: Retrospective
Official Title: Minirin Melt Tolerance With Nocturia in the Common Practice Conditions in Czech Republic
Study Start Date : September 2008
Primary Completion Date : December 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of participants with nocturnal voiding [ Time Frame: 12 months ]
  2. Number of participants with adverse events [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222598


Locations
Czech Republic
Private Ambulance
Blansko, Czech Republic
Private Ambulance
Brno-Zábrdovice, 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
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
Hospital with Polyclinic Nový Jičín
Nový Jičín, Czech Republic
Private Ambulance
Nový Jičín, Czech Republic
University Hospital Olomouc
Olomouc, Czech Republic
City Hospital Ostrava
Ostrava, Czech Republic
Hospital Ostrava
Ostrava, Czech Republic
Private Ambulance
Ostrava, Czech Republic
Private Ambulance
Prague 10, 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
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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01222598     History of Changes
Other Study ID Numbers: FE992026 CS38
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs