A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

May 23, 2016 updated by: Ferring Pharmaceuticals

A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4136

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
      • Benešov, Czech Republic
        • Nemocnice Rudolfa a Stefanie (there may be other sites in this country)
      • Benešov, Czech Republic
        • Soukromá ambulance, Benešov
      • Beroun, Czech Republic
        • Soukromá ambulance Beroun
      • Bohunín, Czech Republic
        • Slezská urologie
      • Brno, Czech Republic
        • Urocentrum Brno
      • Brno, Czech Republic
        • URIONTEGRITAS soukromá ambulance
      • Brno, Czech Republic
        • Uro - clinic
      • Brno, Czech Republic
        • Úrazová nemocnice Brno
      • Citonice, Czech Republic
        • Soukromá ambalance
      • Domažlice, Czech Republic
        • Domažlická Nemocnice
      • Dvůr Králové nad Labem, Czech Republic
        • Městská nemocnice Dvůr Králové nad Labem a.s.
      • Havlíčkův Brod, Czech Republic
        • Nemocnice Havlíčkův Brod
      • Havířov, Czech Republic
        • Nemocnice s poliklinkou Havířov
      • Hluk, Czech Republic
        • Gynekologická ambulance Hluk
      • Hradec Králové, Czech Republic
        • Fakultni nemocnice Hradec Kralove
      • Hradec Králové, Czech Republic
        • PPCHC Sanus Hradec Králové
      • Hustopeče u Brna, Czech Republic
        • Městská nemocnice Hustopeče
      • Jaroměř, Czech Republic
        • Urologická ambulance UROLA
      • Jilemnice, Czech Republic
        • Soukromá ambulance, Jilemnice
      • Kladno, Czech Republic
        • Oblastni nemocnice Kladno a.s.
      • Klatovy, Czech Republic
        • Urologie s.r.o.
      • Krnov, Czech Republic
        • Soukromá ambulance Krnov
      • Kromeriz, Czech Republic
        • Kromerizska nemocnice a.s.
      • Lanškroun, Czech Republic
        • Soukromá ambulance, Lanškroun
      • Mohelnice, Czech Republic
        • Soukromá ambulance Mohelnice
      • Nový Jičín, Czech Republic
        • Sourkomá ambulance, Nový Jičín
      • Nový Jíčín, Czech Republic
        • Nemocnice Novy Jicin
      • Náchod, Czech Republic
        • Oblastni nemocnice Nachod
      • Olomouc, Czech Republic
        • FN Olomouc
      • Olomouc, Czech Republic
        • Centrum MEDIOL s.r.o.
      • Ostrava, Czech Republic
        • Mestska nemocnice Ostrava
      • Ostrava Ploskovice, Czech Republic
        • Gynekologická ambulance
      • Ostrava-Vítkovice, Czech Republic
        • Vitkovicka nemocnice a.s.
      • Pelhřimov, Czech Republic
        • Nemocnice Pelhrimov
      • Plzeň, Czech Republic
        • FN Plzen
      • Plzeň, Czech Republic
        • Poliklinika Denisovo nábřeží
      • Prachatice, Czech Republic
        • Urologická ambulance
      • Praha 1, Czech Republic
        • Urologická klinika Praha 1
      • Praha 10, Czech Republic
        • Urologie Zahradní Město s.r.o.
      • Praha 10 - Uhříněves, Czech Republic
        • Urologie - NZZ Lékařský dům
      • Praha 2, Czech Republic
        • Nemocnice s poliklinikou Praha Italská
      • Praha 2, Czech Republic
        • VFN
      • Praha 4, Czech Republic
        • MEDICON
      • Praha 4, Czech Republic
        • Urologické oddělení
      • Praha 5, Czech Republic
        • Soukromá ambulance, Praha 5
      • Praha 6, Czech Republic
        • Urocare
      • Praha 6, Czech Republic
        • Ustredni vojenska nemocnice
      • Praha 7, Czech Republic
        • Soukromá ambulance Praha 7
      • Praha 8, Czech Republic
        • FN Bulovka
      • Praha 8, Czech Republic
        • Urosanté s.r.o
      • Písek, Czech Republic
        • Nemocnice Písek
      • Přerov, Czech Republic
        • JR Urocentrum Přerov s.r.o.
      • Přeštice, Czech Republic
        • Soukromá ambulance, Přeštice
      • Teplice, Czech Republic
        • Krajská Zdravotní - Nemocnice Teplice
      • Trutnov, Czech Republic
        • Urologická ambulance
      • Turnov, Czech Republic
        • Městská nemocnice Turnov
      • Tábor, Czech Republic
        • Nemocnice Tábor
      • Třebíč, Czech Republic
        • Nemocnice Třebíč
      • Třinec, Czech Republic
        • Nemocnice Podlesí a.s.
      • Uherské Hradiště, Czech Republic
        • Nemocnice Uherské Hradiště
      • Valašské Meziříčí, Czech Republic
        • Nemocnice Valašské Meziříčí
      • Zlín, Czech Republic
        • DUAM s.r.o. Lékařský dům
      • Zlín, Czech Republic
        • Krajská nemocnice T.Bati a.s.
      • Zlín, Czech Republic
        • Soukromá ambulance, Zlín
      • Znojmo, Czech Republic
        • UROKAN s.r.o.
      • Ústí nad Labem, Czech Republic
        • Masarykova Nemocnice V Usti Nad Labem
      • Říčany, Czech Republic
        • Urocare s.r.o.
      • Štemberk, Czech Republic
        • Soukromá ambulance Štemberk

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Patients Suffering From Nocturia 1x or More Times a Night

Description

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

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of changes in dosage regime
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000056

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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