Nocturnal EnuresisMELTNCT01368913
MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis
An observational study of Nocturnal Enuresis, run by Ferring Pharmaceuticals at 73 sites in Germany.
Trial summary
Desmopressin in treatment of nocturnal enuresis (bedwetting). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Nocturnal Enuresis
- How many people
- 138 participants
- Where
- 73 sitesGermany
- Study dates
- Jun 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary nocturnal enuresis
Who may be able to join
- 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.
Who cannot join
- The prescription of Minirin® tablets / Minirin® orally disintegrating tablet (fast dissolving desmopressin) is contraindicated
Trial locations and contacts
73 sites in 1 country.
73 sites in 1 country
Germany73 sites
Investigational Site
Bad Bergzaben
Investigational Site, Kaiserdamm 26
Berlin
Investigational Site, Mahlsdorfer Straße 39-40
Berlin
Investigational Site, Neckarstrasse 7
Berlin
Investigational Site, Potsdamer Chussee 80
Berlin
Investigational Site
Bingen
Investigational Site, Zossener Damm 42
Blankenfelde
Investigational Site , An der Ziegelei 8
Bonn
Investigational Site, Reichsstraße 51
Bonn
Investigational Site
Brackenheim
Investigational Site
Brunsbüttel
Investigational Site
Cologne
Investigational Site
Crailsheim
Investigational Site
Dresden
Investigational Site
Duisburg
Investigational Site, Suitberutsstraße 31
Düsseldorf
Investigational Site, Westfalenstraße 26
Düsseldorf
Investigational Site
Düsseldorf
Investigational Site
Erfurt
Investigational Site
Espelkamp
Investigational Site
Ettenheim
Investigational Site
Forchheim
Investigational Site
Frankfurt am Main
Investigational Site
Friedberg
Investigational Site
Fulda
Investigational Site
Gelsenkirchen
Investigational Site
Germering
Investigational Site
Gernsbach
Investigational Site
Gilching
Investigational Site
Görlitz
Investigational Site
Groß-Umstadt
Investigational Site
Großenhain
Investigational Site
Großröhrsdorf
Investigational Site
Hammelburg
Investigational Site
Hanover
Investigational Site
Harsewinkel-Greffen
Investigational Site
Homburg/Saar
Investigational Site
Hürth
Investigational Site
Hüttenberg
Investigational Site
Itzehoe
Investigational Site
Karlsruhe
Medical Faculty of University Clinic - Schwanenweg 20
Kiel
Investigational Site
Königswinter-Oberpl.
Investigational Site, Neue Linner Straße 77
Krefeld
Investigational Site
Langerwehe
Investigational Site
Lehrte
Investigational Site
Lengerich
Investigational Site
Leverkusen-Schlebusch
Investigational Site
Minden
Investigational Site
Mönchengladbach
Investigational Site
Mutzschen
Investigational Site
Neu Wulmstorf
Investigational Site
Neumünster
Investigational Site
Oberhausen
Investigational Site
Oederan
Investigational Site, Waldstraße 43
Offenbach
Investigational Site
Offenbach
Investigational Site
Oldenburg
Investigational Site
Ottobrunn bei München
Investigational Site
Potsdam
Investigational Site
Rothenburg
Investigational Site
Rottweil
Investigational Site
Rüsselsheim am Main
Investigational Site
Schopfheim
Investigational Site
Schwabach
Investigational Site
Strausberg
Investigational Site
Traunstein
Investigational Site
Trittau
Investigational Site
Varel
Investigational Site
Wertheim am Main
Investigational Site
Wiefelstede
Investigational Site
Wilkau-Haßlau
Investigational Site
Wuppertal
About this study
Official title: 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).
- Conditions
- Nocturnal Enuresis
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with orally disintegrating tablet | Not described | |
| Patients treated with tablets | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patient and parent satisfaction
Measured: 3 months
Secondary outcomes (4)
Number of wet nights
Measured: 3 months
Assessment of drinking volume
Measured: 3 months
Assessment of urine volume
Measured: 3 months
Assessment of patient compliance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Arzneimittel GmbH
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368913
- Sponsor's protocol ID
- 000018
- Acronym
- MELT
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2011
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis With Special Focus on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT01368913
- Acronym / sponsor ID
- MELT / 000018
- Conditions
- Nocturnal Enuresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Arzneimittel GmbH
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Desmopressin in treatment of nocturnal enuresis (bedwetting).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with orally disintegrating tablet | – | – |
| Patients treated with tablets | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary nocturnal enuresis
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The prescription of Minirin® tablets / Minirin® orally disintegrating tablet (fast dissolving desmopressin) is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of patient and parent satisfaction
Time frame: 3 months
4 secondary outcomes
Number of wet nights
Time frame: 3 months
Assessment of drinking volume
Time frame: 3 months
Assessment of urine volume
Time frame: 3 months
Assessment of patient compliance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
73 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Enuresis, run by Ferring Pharmaceuticals at 73 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of patient and parent satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.