NCT01222598

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
588

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

37 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

September 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

October 5, 2010

Last Update Submit

October 5, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    12 months

Secondary Outcomes (2)

  • Number of participants with nocturnal voiding

    12 months

  • Number of participants with adverse events

    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:

  • patients suffering from 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 (37)

Private Ambulance

Blansko, Czechia

Location

Private Ambulance

Brno, Czechia

Location

Trauma Hospital in Brno

Brno, Czechia

Location

Urocentrum

Brno, Czechia

Location

Uromeda, s.r.o.

Brno, Czechia

Location

Private Ambulance

Brno-Zábrdovice, Czechia

Location

Private Ambulance

Bystřice pod Hostýnem, Czechia

Location

Hospital Dečín

Děčín, Czechia

Location

University Hospital Hradec Králové

Hradec Králové, Czechia

Location

Hospital Jablonec nad Nisou

Jablonec nad Nisou, Czechia

Location

Hospital Jihlava

Jihlava, Czechia

Location

Hospital Kroměříž

Kroměříž, Czechia

Location

Polyclinic Kuřim

Kuřim, Czechia

Location

Private Ambulance

Moravský Krumlov, Czechia

Location

Hospital Nové Město na Moravě

Nové Město na Moravě, Czechia

Location

Hospital with Polyclinic Nový Jičín

Nový Jičín, Czechia

Location

Private Ambulance

Nový Jičín, Czechia

Location

University Hospital Olomouc

Olomouc, Czechia

Location

City Hospital Ostrava

Ostrava, Czechia

Location

Hospital Ostrava

Ostrava, Czechia

Location

Private Ambulance

Ostrava, Czechia

Location

Central Military Hospital

Prague, Czechia

Location

Medicon, s.r.o.

Prague, Czechia

Location

Polyclinic Barandov

Prague, Czechia

Location

Private Ambulance

Prague, Czechia

Location

Railway Hospital

Prague, Czechia

Location

Thomayer´s Hospital

Prague, Czechia

Location

University Hospital Bulovka

Prague, Czechia

Location

Hospital Prostějov

Prostějov, Czechia

Location

Private Ambulance

Přerov, Czechia

Location

Hospital Šumperk

Šumperk, Czechia

Location

Private Ambulance

Třebíč, Czechia

Location

Hospital Uherské Hradiště

Uherské Hradiště, Czechia

Location

Hospital Ústí nad Orlicí, Inc

Ústí nad Orlicí, Czechia

Location

Hospital Valašské Meziříčí, Inc

Valašské Meziříčí, Czechia

Location

T. Bata Regional Hospital, Inc.

Zlín, Czechia

Location

Hospital Znojmo

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

October 5, 2010

First Posted

October 18, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations