A Study of Minirin Melt in Patients With Nocturia

October 5, 2012 updated by: Ferring Pharmaceuticals

Minirin Melt Tolerance With Nocturia in the Common Practice Conditions in Czech Republic

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

588

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Blansko, Czech Republic
        • Private Ambulance
      • Brno, Czech Republic
        • Urocentrum
      • Brno, Czech Republic
        • Private Ambulance
      • Brno, Czech Republic
        • Trauma Hospital in Brno
      • Brno, Czech Republic
        • Uromeda, s.r.o.
      • Brno-Zábrdovice, Czech Republic
        • Private Ambulance
      • Bystřice pod Hostýnem, Czech Republic
        • Private Ambulance
      • Děčín, Czech Republic
        • Hospital Dečín
      • Hradec Králové, Czech Republic
        • University Hospital Hradec Kralove
      • Jablonec nad Nisou, Czech Republic
        • Hospital Jablonec nad Nisou
      • Jihlava, Czech Republic
        • Hospital Jihlava
      • Kroměříž, Czech Republic
        • Hospital Kroměříž
      • Kuřim, Czech Republic
        • Polyclinic Kuřim
      • Moravský Krumlov, Czech Republic
        • Private Ambulance
      • Nové Město na Moravě, Czech Republic
        • Hospital Nové Město na Moravě
      • Nový Jičín, Czech Republic
        • Private Ambulance
      • Nový Jičín, Czech Republic
        • Hospital with Polyclinic Nový Jičín
      • Olomouc, Czech Republic
        • University Hospital Olomouc
      • Ostrava, Czech Republic
        • City Hospital Ostrava
      • Ostrava, Czech Republic
        • Hospital Ostrava
      • Ostrava, Czech Republic
        • Private Ambulance
      • Prague, Czech Republic
        • University Hospital Bulovka
      • Prague, 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 10, Czech Republic
        • Private Ambulance
      • Praha 4, Czech Republic
        • Private Ambulance
      • Prostějov, Czech Republic
        • Hospital Prostějov
      • Přerov, Czech Republic
        • Private Ambulance
      • Třebíč, Czech Republic
        • Private Ambulance
      • Uherské Hradiště, Czech Republic
        • Hospital Uherské Hradiště
      • Valašské Meziříčí, Czech Republic
        • Hospital Valašské Meziříčí, Inc
      • Zlín, Czech Republic
        • T. Bata Regional Hospital, Inc.
      • Znojmo, Czech Republic
        • Hospital Znojmo
      • Ústí nad Orlicí, Czech Republic
        • Hospital Ústí nad Orlicí, Inc
      • Šumperk, Czech Republic
        • Hospital Šumperk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 12 months
12 months
Number of participants with nocturnal voiding
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

October 5, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE992026 CS38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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