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Desmopressin Melt: Impact on Sleep and Daytime Functioning
Plain-language guide to NCT01645475: phase 4 interventional trial of Desmopressin, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01645475
- Phase
- phase 4
- Status
- completed
- Start
- 2011-04
- Completion (planned or actual)
- 2012-08
- Participants
- 30 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Monosymptomatic Nocturnal Enuresis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Desmopressin.
Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion, the synthetic AVP analogue desmopressin is widely used to treat MNE.
It is recommended by the International Consultation on Incontinence (grade A,level 1).
It had 1 arm (groups): Desmopressin lyophilisate (Melt) (experimental).
Patients receiving Desmopressin lyophilisate (Melt).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 30 actual participants took part.
It was open to people of any sex aged from 6 years up to 16 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 6 to 16 years. Monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: mental retardation; autism spectrum disorders; daytime incontinence resistant to therapy.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Desmopressin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-04 with completion listed for 2012-08.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Bladder information: voiding calender (time frame: Change between day 1 before start of studymedication and 6 months later). Urine concentration (time frame: Change between day 1 before start of studymedication and 6 months later). IQ (Intelligent Quotient) (time frame: Change between day 1 before start of studymedication and 6 months later).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Desmopressin in 30 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Desmopressin compound page, all human trials.
Our Notes on the Compound
Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.