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

June 11, 2013 updated by: Ferring Pharmaceuticals

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

Desmopressin in treatment of nocturnal enuresis (bedwetting).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Bergzabern, Germany
        • Investigational Site
      • Berlin, 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
      • Bingen, Germany
        • Investigational Site
      • Blankenfelde, Germany
        • Investigational Site, Zossener Damm 42
      • Bonn, Germany
        • Investigational Site , An der Ziegelei 8
      • Bonn, Germany
        • Investigational Site, Reichsstraße 51
      • Brackenheim, Germany
        • Investigational Site
      • Brunsbüttel, Germany
        • Investigational Site
      • Crailsheim, Germany
        • Investigational Site
      • Dresden, Germany
        • Investigational Site
      • Duisburg, Germany
        • Investigational Site
      • Düsseldorf, Germany
        • Investigational Site
      • Düsseldorf, Germany
        • Investigational Site, Suitberutsstraße 31
      • Düsseldorf, Germany
        • Investigational Site, Westfalenstraße 26
      • 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
      • Groß-Umstadt, Germany
        • Investigational Site
      • Großenhain, Germany
        • Investigational Site
      • Großröhrsdorf, Germany
        • Investigational Site
      • Görlitz, 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
        • Investigational Site
      • Kiel, Germany
        • Medical Faculty of University Clinic - Schwanenweg 20
      • Krefeld, Germany
        • Investigational Site, Neue Linner Straße 77
      • Köln, Germany
        • Investigational Site
      • Königswinter-Oberpl., Germany
        • Investigational Site
      • Langerwehe, Germany
        • Investigational Site
      • Lehrte, Germany
        • Investigational Site
      • Lengerich, Germany
        • Investigational Site
      • Leverkusen-Schlebusch, Germany
        • Investigational Site
      • Minden, Germany
        • Investigational Site
      • Mutzschen, Germany
        • Investigational Site
      • Mönchengladbach, Germany
        • Investigational Site
      • Neu Wulmstorf, Germany
        • Investigational Site
      • Neumünster, Germany
        • Investigational Site
      • Oberhausen, Germany
        • Investigational Site
      • Oederan, Germany
        • Investigational Site
      • Offenbach, Germany
        • Investigational Site
      • Offenbach am Main, Germany
        • Investigational Site, Waldstraße 43
      • 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, Germany
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary nocturnal enuresis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients treated with orally disintegrating tablet
Patients treated with tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of patient and parent satisfaction
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of wet nights
Time Frame: 3 months
3 months
Assessment of drinking volume
Time Frame: 3 months
3 months
Assessment of urine volume
Time Frame: 3 months
3 months
Assessment of patient compliance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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