A Study of Minirin Melt in Patients With Nocturia | NCT01222598 | Trialant

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A Study of Minirin Melt in Patients With Nocturia | NCT01222598 | Trialant

Studies
A Study of Minirin Melt in Patients With Nocturia

NCT01222598

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Oct 8, 2012Estimated

Enrollment

588Actual

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

NCT01222598

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

FE992026 CS38

Secondary IDs

Not provided

Brief Title

A Study of Minirin Melt in Patients With Nocturia

Official Title

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

Acronym

Not provided

Organization

Ferring PharmaceuticalsINDUSTRY

Status Module

Record Verification Date

Oct 2012

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

Sep 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Oct 5, 2010

First Submission Date that Met QC Criteria

Oct 15, 2010

First Posted Date

Oct 18, 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

Oct 5, 2012

Last Update Posted Date

Oct 8, 2012Estimated

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

588Actual

Arms/Interventions Module

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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
Private Ambulance		Blansko			Czechia
Private Ambulance

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.

Brno

Czechia

Trauma Hospital in Brno

Brno

Czechia

Urocentrum

Brno

Czechia

Uromeda, s.r.o.

Brno

Czechia

Private Ambulance

Brno-Zábrdovice

Czechia

Private Ambulance

Bystřice pod Hostýnem

Czechia

Hospital Dečín

Děčín

Czechia

University Hospital Hradec Králové

Hradec Králové

Czechia

Hospital Jablonec nad Nisou

Jablonec nad Nisou

Czechia

Hospital Jihlava

Jihlava

Czechia

Hospital Kroměříž

Kroměříž

Czechia

Polyclinic Kuřim

Kuřim

Czechia

Private Ambulance

Moravský Krumlov

Czechia

Hospital Nové Město na Moravě

Nové Město na Moravě

Czechia

Hospital with Polyclinic Nový Jičín

Nový Jičín

Czechia

Private Ambulance

Nový Jičín

Czechia

University Hospital Olomouc

Olomouc

Czechia

City Hospital Ostrava

Ostrava

Czechia

Hospital Ostrava

Ostrava

Czechia

Private Ambulance

Ostrava

Czechia

Central Military Hospital

Prague

Czechia

Medicon, s.r.o.

Prague

Czechia

Polyclinic Barandov

Prague

Czechia

Private Ambulance

Prague

Czechia

Railway Hospital

Prague

Czechia

Thomayer´s Hospital

Prague

Czechia

University Hospital Bulovka

Prague

Czechia

Hospital Prostějov

Prostějov

Czechia

Private Ambulance

Přerov

Czechia

Hospital Šumperk

Šumperk

Czechia

Private Ambulance

Třebíč

Czechia

Hospital Uherské Hradiště

Uherské Hradiště

Czechia

Hospital Ústí nad Orlicí, Inc

Ústí nad Orlicí

Czechia

Hospital Valašské Meziříčí, Inc

Valašské Meziříčí

Czechia

T. Bata Regional Hospital, Inc.

Zlín

Czechia

Hospital Znojmo

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

Browse Leaves

Not provided

Browse Branches

Not provided