MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

— MELT  

Official title:

MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis With Special Focus on Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368913
• Other study ID #: 000018
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: June 11, 2013
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Desmopressin in treatment of nocturnal enuresis (bedwetting).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis

Locations

Country	Name	City	State
Germany	Investigational Site	Bad Bergzabern
Germany	Investigational Site, Kaiserdamm 26	Berlin
Germany	Investigational Site, Mahlsdorfer Straße 39-40	Berlin
Germany	Investigational Site, Neckarstrasse 7	Berlin
Germany	Investigational Site, Potsdamer Chussee 80	Berlin
Germany	Investigational Site	Bingen
Germany	Investigational Site, Zossener Damm 42	Blankenfelde
Germany	Investigational Site , An der Ziegelei 8	Bonn
Germany	Investigational Site, Reichsstraße 51	Bonn
Germany	Investigational Site	Brackenheim
Germany	Investigational Site	Brunsbüttel
Germany	Investigational Site	Crailsheim
Germany	Investigational Site	Dresden
Germany	Investigational Site	Duisburg
Germany	Investigational Site	Düsseldorf
Germany	Investigational Site, Suitberutsstraße 31	Düsseldorf
Germany	Investigational Site, Westfalenstraße 26	Düsseldorf
Germany	Investigational Site	Erfurt
Germany	Investigational Site	Espelkamp
Germany	Investigational Site	Ettenheim
Germany	Investigational Site	Forchheim
Germany	Investigational Site	Frankfurt / Main
Germany	Investigational Site	Friedberg
Germany	Investigational Site	Fulda
Germany	Investigational Site	Gelsenkirchen
Germany	Investigational Site	Germering
Germany	Investigational Site	Gernsbach
Germany	Investigational Site	Gilching
Germany	Investigational Site	Görlitz
Germany	Investigational Site	Groß-Umstadt
Germany	Investigational Site	Großenhain
Germany	Investigational Site	Großröhrsdorf
Germany	Investigational Site	Hammelburg
Germany	Investigational Site	Hannover
Germany	Investigational Site	Harsewinkel-Greffen
Germany	Investigational Site	Homburg/Saar
Germany	Investigational Site	Hürth
Germany	Investigational Site	Hüttenberg
Germany	Investigational Site	Itzehoe
Germany	Investigational Site	Karlsruhe
Germany	Medical Faculty of University Clinic - Schwanenweg 20	Kiel
Germany	Investigational Site	Köln
Germany	Investigational Site	Königswinter-Oberpl.
Germany	Investigational Site, Neue Linner Straße 77	Krefeld
Germany	Investigational Site	Langerwehe
Germany	Investigational Site	Lehrte
Germany	Investigational Site	Lengerich
Germany	Investigational Site	Leverkusen-Schlebusch
Germany	Investigational Site	Minden
Germany	Investigational Site	Mönchengladbach
Germany	Investigational Site	Mutzschen
Germany	Investigational Site	Neu Wulmstorf
Germany	Investigational Site	Neumünster
Germany	Investigational Site	Oberhausen
Germany	Investigational Site	Oederan
Germany	Investigational Site	Offenbach
Germany	Investigational Site, Waldstraße 43	Offenbach am Main
Germany	Investigational Site	Oldenburg
Germany	Investigational Site	Ottobrunn
Germany	Investigational Site	Potsdam
Germany	Investigational Site	Rothenburg
Germany	Investigational Site	Rottweil
Germany	Investigational Site	Rüsselsheim
Germany	Investigational Site	Schopfheim
Germany	Investigational Site	Schwabach
Germany	Investigational Site	Strausberg
Germany	Investigational Site	Traunstein
Germany	Investigational Site	Trittau
Germany	Investigational Site	Varel
Germany	Investigational Site	Wertheim
Germany	Investigational Site	Wiefelstede
Germany	Investigational Site	Wilkau-Haßlau
Germany	Investigational Site	Wuppertal

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of patient and parent satisfaction		3 months	No
Secondary	Number of wet nights		3 months	No
Secondary	Assessment of drinking volume		3 months	No
Secondary	Assessment of urine volume		3 months	No
Secondary	Assessment of patient compliance		3 months	No