A Study of Minirin Melt in Patients With Nocturia | NCT01212224 | Trialant

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A Study of Minirin Melt in Patients With Nocturia | NCT01212224 | Trialant

Studies
A Study of Minirin Melt in Patients With Nocturia

NCT01212224

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Jan 6, 2014Estimated

Enrollment

2,187Actual

Phase

Not provided

Conditions

Nocturia

Interventions

Not provided

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT01212224

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

FE992026 CS37

Secondary IDs

Not provided

Brief Title

A Study of Minirin Melt in Patients With Nocturia

Official Title

Retrospective Safety Study in 12 Months Treatment Nocturia With Minirin Melt in Clinical Practice in Czech Republic

Acronym

Not provided

Organization

Ferring PharmaceuticalsINDUSTRY

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jan 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 29, 2010

First Posted Date

Sep 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2014

Last Update Posted Date

Jan 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Ferring PharmaceuticalsINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Conditions Module

Conditions

Nocturia

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,187Actual

Arms/Interventions Module

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Verify the safety profile		12 months

Secondary Outcomes

Measure	Description	Time Frame
Safety aspect of dosage		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nemocnice Rudolfa a Stefanie		Benešov			Czechia
Private ambulance Benešov

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Retrospective

Masking Info

No data available

No data is available for this block.

Benešov

Czechia

Private ambulance Beroun

Beroun

Czechia

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

Bohumín

Czechia

Health centre Brno

Brno

Czechia

Hospital Accident

Brno

Czechia

Hospital Delta - private ambulance

Brno

Czechia

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

Brno

Czechia

Urocentrum

Brno

Czechia

Private ambulance

Brno - Zábrdovice

Czechia

Soukromá ambulanc Černošice

Černošice

Czechia

Hospital Česká Lípa

Česká Lípa

Czechia

Hospital Děčín

Děčín

Czechia

Domažlická nemocnice a.s.

Domažlice

Czechia

Soukromá ambulance Dvůr Králové

Dvůr Králové

Czechia

Private ambulance

Hanušovice

Czechia

Hospital with health centre

Havířov

Czechia

Hospital Havlíčkův Brod

Havlíčkův Brod

Czechia

Gynekologická ambulance Hluk

Hluk

Czechia

Private ambulance Urologie, s.r.o.

Horšovský Týn

Czechia

Hospital Hradec Králové

Hradec Králové

Czechia

Městská nemocnice Hustopeče

Hustopeč U Brna

Czechia

Private ambulance

Jablonec nad Nisou

Czechia

Soukromá ambulance Jablonec nad Nisou

Jablonec nad Nisou

Czechia

Private ambulance

Jilemnice

Czechia

Hospital ambulance

Karlovy Vary

Czechia

Oblastní nemocnice Kladno

Kladno

Czechia

Hospital Krnov

Krnov

Czechia

Hospital Kromeriz

Kroměříž

Czechia

Soukromá ambulance Kuřim

Kuřim

Czechia

Private ambulance

Lanškroun

Czechia

Soukromá ambulance Mohelnice

Mohelnice

Czechia

Hospital Náchod

Náchod

Czechia

Private ambulance

Nový Jičín

Czechia

Hospital Olomouc

Olomouc

Czechia

Private ambulance - Mediol, s.r.o.

Olomouc

Czechia

City Hospital

Ostrava

Czechia

Private ambulance

Ostrava - Poruba

Czechia

Vítkovická hospital

Ostrava - Vítkovice

Czechia

Hospital Pelhřimov

Pelhřimov

Czechia

Hospital Plzeň

Pilsen

Czechia

Private ambulance Plzeň

Pilsen

Czechia

Hospital Písek

Písek

Czechia

Private ambulance Prachatice

Prachatice

Czechia

Hospital Bulovka

Prague

Czechia

Hospital Želeniční nemocnice

Prague

Czechia

Medicon

Prague

Czechia

Private ambulance - Urosante s.r.o.

Prague

Czechia

Private ambulance Praha 4

Prague

Czechia

Private ambulance Praha 5

Prague

Czechia

Private ambulance

Prague

Czechia

Private gyn. ambulance

Prague

Czechia

Privátní ambulance Dr. A. Antončík

Prague

Czechia

Thomayer Hospital

Prague

Czechia

Urocare

Prague

Czechia

Urocentrum Praha 2

Prague

Czechia

Urology clinic Hospital Praha

Prague

Czechia

Všeobecná fakultní nemocnice

Prague

Czechia

Hospital Přerov

Přerov

Czechia

Private ambulance - Preštice

Přeštice

Czechia

Private ambulance

Rakovník

Czechia

Soukromá ambulance Roudnice nad Labem

Roudnice nad Labem

Czechia

Private ambulance

Rožnov pod Radhoštěm

Czechia

Hospital Řičany - private ambulance

Říčany

Czechia

Soukromá ambulance Štenberk

Štenberk

Czechia

Private ambulance

Šumperk

Czechia

Šumperská nemocnice

Šumperk

Czechia

Hospital Tábor

Tábor

Czechia

Hospital ambulance

Teplice

Czechia

Hospital Třebíč

Třebíč

Czechia

Hospital Podlesí,s.r.o.

Třinec

Czechia

Panoch Hospital

Turnov

Czechia

Hospital with health centre

Uherské Hradiště

Czechia

Masaryk Hospital

Ústí nad Labem

Czechia

Hospital Ústí nad Orlicí

Ústí nad Orlicí

Czechia

Nemocnice Valašské Meziříčí

Valašské Meziřící

Czechia

Krajská nemocnice T. Bati

Zlín

Czechia

Medel, s.r.o.

Zlín

Czechia

Private ambulance Lékařský dům

Zlín

Czechia

Private ambulance

Zlín

Czechia

UROKAN, s.r.o.

Znojmo

Czechia

ID	Term
D053158	Nocturia

Ancestor Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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