NCT01368913

Brief Summary

Desmopressin in treatment of nocturnal enuresis (bedwetting).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

73 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

June 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

June 7, 2011

Last Update Submit

June 11, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of patient and parent satisfaction

    3 months

Secondary Outcomes (4)

  • Number of wet nights

    3 months

  • Assessment of drinking volume

    3 months

  • Assessment of urine volume

    3 months

  • Assessment of patient compliance

    3 months

Study Arms (2)

Patients treated with orally disintegrating tablet

Patients treated with tablets

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary nocturnal enuresis

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (73)

Investigational Site

Bad Bergzaben, Germany

Location

Investigational Site, Kaiserdamm 26

Berlin, Germany

Location

Investigational Site, Mahlsdorfer Straße 39-40

Berlin, Germany

Location

Investigational Site, Neckarstrasse 7

Berlin, Germany

Location

Investigational Site, Potsdamer Chussee 80

Berlin, Germany

Location

Investigational Site

Bingen, Germany

Location

Investigational Site, Zossener Damm 42

Blankenfelde, Germany

Location

Investigational Site , An der Ziegelei 8

Bonn, Germany

Location

Investigational Site, Reichsstraße 51

Bonn, Germany

Location

Investigational Site

Brackenheim, Germany

Location

Investigational Site

Brunsbüttel, Germany

Location

Investigational Site

Cologne, Germany

Location

Investigational Site

Crailsheim, Germany

Location

Investigational Site

Dresden, Germany

Location

Investigational Site

Duisburg, Germany

Location

Investigational Site, Suitberutsstraße 31

Düsseldorf, Germany

Location

Investigational Site, Westfalenstraße 26

Düsseldorf, Germany

Location

Investigational Site

Düsseldorf, Germany

Location

Investigational Site

Erfurt, Germany

Location

Investigational Site

Espelkamp, Germany

Location

Investigational Site

Ettenheim, Germany

Location

Investigational Site

Forchheim, Germany

Location

Investigational Site

Frankfurt am Main, Germany

Location

Investigational Site

Friedberg, Germany

Location

Investigational Site

Fulda, Germany

Location

Investigational Site

Gelsenkirchen, Germany

Location

Investigational Site

Germering, Germany

Location

Investigational Site

Gernsbach, Germany

Location

Investigational Site

Gilching, Germany

Location

Investigational Site

Görlitz, Germany

Location

Investigational Site

Groß-Umstadt, Germany

Location

Investigational Site

Großenhain, Germany

Location

Investigational Site

Großröhrsdorf, Germany

Location

Investigational Site

Hammelburg, Germany

Location

Investigational Site

Hanover, Germany

Location

Investigational Site

Harsewinkel-Greffen, Germany

Location

Investigational Site

Homburg/Saar, Germany

Location

Investigational Site

Hürth, Germany

Location

Investigational Site

Hüttenberg, Germany

Location

Investigational Site

Itzehoe, Germany

Location

Investigational Site

Karlsruhe, Germany

Location

Medical Faculty of University Clinic - Schwanenweg 20

Kiel, Germany

Location

Investigational Site

Königswinter-Oberpl., Germany

Location

Investigational Site, Neue Linner Straße 77

Krefeld, Germany

Location

Investigational Site

Langerwehe, Germany

Location

Investigational Site

Lehrte, Germany

Location

Investigational Site

Lengerich, Germany

Location

Investigational Site

Leverkusen-Schlebusch, Germany

Location

Investigational Site

Minden, Germany

Location

Investigational Site

Mönchengladbach, Germany

Location

Investigational Site

Mutzschen, Germany

Location

Investigational Site

Neu Wulmstorf, Germany

Location

Investigational Site

Neumünster, Germany

Location

Investigational Site

Oberhausen, Germany

Location

Investigational Site

Oederan, Germany

Location

Investigational Site, Waldstraße 43

Offenbach, Germany

Location

Investigational Site

Offenbach, Germany

Location

Investigational Site

Oldenburg, Germany

Location

Investigational Site

Ottobrunn bei München, Germany

Location

Investigational Site

Potsdam, Germany

Location

Investigational Site

Rothenburg, Germany

Location

Investigational Site

Rottweil, Germany

Location

Investigational Site

Rüsselsheim am Main, Germany

Location

Investigational Site

Schopfheim, Germany

Location

Investigational Site

Schwabach, Germany

Location

Investigational Site

Strausberg, Germany

Location

Investigational Site

Traunstein, Germany

Location

Investigational Site

Trittau, Germany

Location

Investigational Site

Varel, Germany

Location

Investigational Site

Wertheim am Main, Germany

Location

Investigational Site

Wiefelstede, Germany

Location

Investigational Site

Wilkau-Haßlau, Germany

Location

Investigational Site

Wuppertal, Germany

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 8, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations