Clinical trial NCT01368913: MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis
Official title: MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis With Special Focus on Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturnal Enuresis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2011-06-08
Enrollment: 138
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary nocturnal enuresis

Brief summary: Desmopressin in treatment of nocturnal enuresis (bedwetting).


Eligibility criteria: Inclusion Criteria:

* Treatment of primary nocturnal enuresis within an overall therapeutical concept, eg, in cases of failure of other non-medicinal therapies or with indication of a medicinal therapy caused by nocturnal ADH deficiency
* The patients and their parents have been informed about the study and have given their written consent for participation.

Exclusion Criteria:

* The prescription of Minirin® tablets / Minirin® orally disintegrating tablet (fast dissolving desmopressin) is contraindicated

Primary outcomes:
measure: Assessment of patient and parent satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Number of wet nights
timeFrame: 3 months
measure: Assessment of drinking volume
timeFrame: 3 months
measure: Assessment of urine volume
timeFrame: 3 months
measure: Assessment of patient compliance
timeFrame: 3 months
Other outcomes:
Locations:
city: Bad Bergzabern
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site, Kaiserdamm 26
city: Berlin
country: Germany
facility: Investigational Site, Mahlsdorfer Straße 39-40
city: Berlin
country: Germany
facility: Investigational Site, Neckarstrasse 7
city: Berlin
country: Germany
facility: Investigational Site, Potsdamer Chussee 80
city: Bingen
country: Germany
facility: Investigational Site
city: Blankenfelde
country: Germany
facility: Investigational Site, Zossener Damm 42
city: Bonn
country: Germany
facility: Investigational Site , An der Ziegelei 8
city: Bonn
country: Germany
facility: Investigational Site, Reichsstraße 51
city: Brackenheim
country: Germany
facility: Investigational Site
city: Brunsbüttel
country: Germany
facility: Investigational Site
city: Crailsheim
country: Germany
facility: Investigational Site
city: Dresden
country: Germany
facility: Investigational Site
city: Duisburg
country: Germany
facility: Investigational Site
city: Düsseldorf
country: Germany
facility: Investigational Site, Suitberutsstraße 31
city: Düsseldorf
country: Germany
facility: Investigational Site, Westfalenstraße 26
city: Düsseldorf
country: Germany
facility: Investigational Site
city: Erfurt
country: Germany
facility: Investigational Site
city: Espelkamp
country: Germany
facility: Investigational Site
city: Ettenheim
country: Germany
facility: Investigational Site
city: Forchheim
country: Germany
facility: Investigational Site
city: Frankfurt / Main
country: Germany
facility: Investigational Site
city: Friedberg
country: Germany
facility: Investigational Site
city: Fulda
country: Germany
facility: Investigational Site
city: Gelsenkirchen
country: Germany
facility: Investigational Site
city: Germering
country: Germany
facility: Investigational Site
city: Gernsbach
country: Germany
facility: Investigational Site
city: Gilching
country: Germany
facility: Investigational Site
city: Groß-Umstadt
country: Germany
facility: Investigational Site
city: Großenhain
country: Germany
facility: Investigational Site
city: Großröhrsdorf
country: Germany
facility: Investigational Site
city: Görlitz
country: Germany
facility: Investigational Site
city: Hammelburg
country: Germany
facility: Investigational Site
city: Hannover
country: Germany
facility: Investigational Site
city: Harsewinkel-Greffen
country: Germany
facility: Investigational Site
city: Homburg/Saar
country: Germany
facility: Investigational Site
city: Hürth
country: Germany
facility: Investigational Site
city: Hüttenberg
country: Germany
facility: Investigational Site
city: Itzehoe
country: Germany
facility: Investigational Site
city: Karlsruhe
country: Germany
facility: Investigational Site
city: Kiel
country: Germany
facility: Medical Faculty of University Clinic - Schwanenweg 20
city: Krefeld
country: Germany
facility: Investigational Site, Neue Linner Straße 77
city: Köln
country: Germany
facility: Investigational Site
city: Königswinter-Oberpl.
country: Germany
facility: Investigational Site
city: Langerwehe
country: Germany
facility: Investigational Site
city: Lehrte
country: Germany
facility: Investigational Site
city: Lengerich
country: Germany
facility: Investigational Site
city: Leverkusen-Schlebusch
country: Germany
facility: Investigational Site
city: Minden
country: Germany
facility: Investigational Site
city: Mutzschen
country: Germany
facility: Investigational Site
city: Mönchengladbach
country: Germany
facility: Investigational Site
city: Neu Wulmstorf
country: Germany
facility: Investigational Site
city: Neumünster
country: Germany
facility: Investigational Site
city: Oberhausen
country: Germany
facility: Investigational Site
city: Oederan
country: Germany
facility: Investigational Site
city: Offenbach am Main
country: Germany
facility: Investigational Site, Waldstraße 43
city: Offenbach
country: Germany
facility: Investigational Site
city: Oldenburg
country: Germany
facility: Investigational Site
city: Ottobrunn
country: Germany
facility: Investigational Site
city: Potsdam
country: Germany
facility: Investigational Site
city: Rothenburg
country: Germany
facility: Investigational Site
city: Rottweil
country: Germany
facility: Investigational Site
city: Rüsselsheim
country: Germany
facility: Investigational Site
city: Schopfheim
country: Germany
facility: Investigational Site
city: Schwabach
country: Germany
facility: Investigational Site
city: Strausberg
country: Germany
facility: Investigational Site
city: Traunstein
country: Germany
facility: Investigational Site
city: Trittau
country: Germany
facility: Investigational Site
city: Varel
country: Germany
facility: Investigational Site
city: Wertheim
country: Germany
facility: Investigational Site
city: Wiefelstede
country: Germany
facility: Investigational Site
city: Wilkau-Haßlau
country: Germany
facility: Investigational Site
city: Wuppertal
country: Germany
facility: Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: