NCT01212224

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,187

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

81 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

September 21, 2010

Last Update Submit

January 3, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Verify the safety profile

    12 months

Secondary Outcomes (1)

  • Safety aspect of dosage

    12 months

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • nocturia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (81)

Nemocnice Rudolfa a Stefanie

Benešov, Czechia

Location

Private ambulance Benešov

Benešov, Czechia

Location

Private ambulance Beroun

Beroun, Czechia

Location

Private ambulance - Slezská urologie, s.r.o.

Bohumín, Czechia

Location

Health centre Brno

Brno, Czechia

Location

Hospital Accident

Brno, Czechia

Location

Hospital Delta - private ambulance

Brno, Czechia

Location

Private ambulance Uro-Clinic, s.r.o.

Brno, Czechia

Location

Urocentrum

Brno, Czechia

Location

Private ambulance

Brno - Zábrdovice, Czechia

Location

Soukromá ambulanc Černošice

Černošice, Czechia

Location

Hospital Česká Lípa

Česká Lípa, Czechia

Location

Hospital Děčín

Děčín, Czechia

Location

Domažlická nemocnice a.s.

Domažlice, Czechia

Location

Soukromá ambulance Dvůr Králové

Dvůr Králové, Czechia

Location

Private ambulance

Hanušovice, Czechia

Location

Hospital with health centre

Havířov, Czechia

Location

Hospital Havlíčkův Brod

Havlíčkův Brod, Czechia

Location

Gynekologická ambulance Hluk

Hluk, Czechia

Location

Private ambulance Urologie, s.r.o.

Horšovský Týn, Czechia

Location

Hospital Hradec Králové

Hradec Králové, Czechia

Location

Městská nemocnice Hustopeče

Hustopeč U Brna, Czechia

Location

Private ambulance

Jablonec nad Nisou, Czechia

Location

Soukromá ambulance Jablonec nad Nisou

Jablonec nad Nisou, Czechia

Location

Private ambulance

Jilemnice, Czechia

Location

Hospital ambulance

Karlovy Vary, Czechia

Location

Oblastní nemocnice Kladno

Kladno, Czechia

Location

Hospital Krnov

Krnov, Czechia

Location

Hospital Kromeriz

Kroměříž, Czechia

Location

Soukromá ambulance Kuřim

Kuřim, Czechia

Location

Private ambulance

Lanškroun, Czechia

Location

Soukromá ambulance Mohelnice

Mohelnice, Czechia

Location

Hospital Náchod

Náchod, Czechia

Location

Private ambulance

Nový Jičín, Czechia

Location

Hospital Olomouc

Olomouc, Czechia

Location

Private ambulance - Mediol, s.r.o.

Olomouc, Czechia

Location

City Hospital

Ostrava, Czechia

Location

Private ambulance

Ostrava - Poruba, Czechia

Location

Vítkovická hospital

Ostrava - Vítkovice, Czechia

Location

Hospital Pelhřimov

Pelhřimov, Czechia

Location

Hospital Plzeň

Pilsen, Czechia

Location

Private ambulance Plzeň

Pilsen, Czechia

Location

Hospital Písek

Písek, Czechia

Location

Private ambulance Prachatice

Prachatice, Czechia

Location

Hospital Bulovka

Prague, Czechia

Location

Hospital Želeniční nemocnice

Prague, Czechia

Location

Medicon

Prague, Czechia

Location

Private ambulance - Urosante s.r.o.

Prague, Czechia

Location

Private ambulance Praha 4

Prague, Czechia

Location

Private ambulance Praha 5

Prague, Czechia

Location

Private ambulance

Prague, Czechia

Location

Private gyn. ambulance

Prague, Czechia

Location

Privátní ambulance Dr. A. Antončík

Prague, Czechia

Location

Thomayer Hospital

Prague, Czechia

Location

Urocare

Prague, Czechia

Location

Urocentrum Praha 2

Prague, Czechia

Location

Urology clinic Hospital Praha

Prague, Czechia

Location

Všeobecná fakultní nemocnice

Prague, Czechia

Location

Hospital Přerov

Přerov, Czechia

Location

Private ambulance - Preštice

Přeštice, Czechia

Location

Private ambulance

Rakovník, Czechia

Location

Soukromá ambulance Roudnice nad Labem

Roudnice nad Labem, Czechia

Location

Private ambulance

Rožnov pod Radhoštěm, Czechia

Location

Hospital Řičany - private ambulance

Říčany, Czechia

Location

Soukromá ambulance Štenberk

Štenberk, Czechia

Location

Private ambulance

Šumperk, Czechia

Location

Šumperská nemocnice

Šumperk, Czechia

Location

Hospital Tábor

Tábor, Czechia

Location

Hospital ambulance

Teplice, Czechia

Location

Hospital Třebíč

Třebíč, Czechia

Location

Hospital Podlesí,s.r.o.

Třinec, Czechia

Location

Panoch Hospital

Turnov, Czechia

Location

Hospital with health centre

Uherské Hradiště, Czechia

Location

Masaryk Hospital

Ústí nad Labem, Czechia

Location

Hospital Ústí nad Orlicí

Ústí nad Orlicí, Czechia

Location

Nemocnice Valašské Meziříčí

Valašské Meziřící, Czechia

Location

Krajská nemocnice T. Bati

Zlín, Czechia

Location

Medel, s.r.o.

Zlín, Czechia

Location

Private ambulance Lékařský dům

Zlín, Czechia

Location

Private ambulance

Zlín, Czechia

Location

UROKAN, s.r.o.

Znojmo, Czechia

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 30, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations