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Desmopressin for Bedwetting in Children With SCD
Plain-language guide to NCT04420585: phase 4 interventional trial of Desmopressin, anemia, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04420585
- Phase
- phase 4
- Status
- terminated early
- Start
- 2020-07-07
- Completion (planned or actual)
- 2023-06-12
- Participants
- 8 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Nocturnal Enuresis; Anemia, Sickle Cell
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Desmopressin for anemia.
It had 1 arm (groups): Treatment Group (experimental).
The registry classes the interventions as drug.
More on the Plan
This trial will inform pediatric sickle cell doctors if desmopressin is an appropriate treatment for bed wetting in the investigators patients.
This study expanded upon a previously terminated study which had separately registered (NCT02636387, ID: 2014-3768).
Who Took Part
The registry lists 8 actual participants took part.
It was open to people of any sex aged from 8 years up to 21 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with Hemoglobin SS, SC, SB0thal or SB+thal. Patients with at least two episodes of primary nocturnal enuresis per week or four episodes over the two weeks prior to enrollment. Patients with secondary enuresis who have been evaluated and cleared by a pediatric urologist as not having other etiologies of enuresis (e.g. overactive detrusor activity, a genitourinary anatomic abnormality).
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patients with developmental delay or neurologic dysfunction secondary to stroke; patients with hypertension or underlying renal disease; patients with genitourinary anatomic abnormalities. any prior renal ultrasound showing normal genitourinary anatomy is sufficient to clear a patient for the study.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Desmopressin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2020-07-07 with completion listed for 2023-06-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Bedwetting Episodes (time frame: Baseline and ~1 month).
It also tracked 3 secondary outcomes, for example Impact of Bedwetting on Day to Day Activities, Change in Nighttime Awakenings and Change in Daytime Fatigue.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Desmopressin in 8 people with anemia.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Desmopressin compound page, Anemia research.
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.