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Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Plain-language guide to NCT02538302: phase 3 randomized trial of Desmopressin, 66 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02538302
- Phase
- phase 3
- Status
- completed
- Start
- 2013-07
- Completion (planned or actual)
- 2015-07
- Participants
- 66 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Nocturnal Enuresis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Desmopressin.
Nocturnal enuresis is among the most common disorders in children.
It had two arms (groups): Minirin (experimental) and Oxybutynin (active comparator).
The registry classes the interventions as drug.
Who Took Part
66 actual participants took part.
It was open to people of any sex aged from 5 years up to 14 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: \>5 years old.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: children who their parents did noted filled the informed consent form; impossibility of follow up during the study period; history of seizure.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.
The Desmopressin group and the comparison group ran side by side rather than switching.
As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2013-07 with completion listed for 2015-07.
It ran at 1 site in Iran.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): ّFrequency of nocturnal enuresis (time frame: 6 months).
It also tracked 17 secondary outcomes, for example Frequency of urinary incontinency, Frequency of urgency, Frequency of Xerostomia, Frequency of Xerophthalmia, Frequency of Blurred vision and Frequency of Dysphagia.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Desmopressin in 66 people.
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.