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Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
Plain-language guide to NCT00902655: phase 4 interventional trial of Desmopressin, 103 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00902655
- Phase
- phase 4
- Status
- completed
- Start
- 2004-04
- Completion (planned or actual)
- 2005-12
- Participants
- 103 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Nocturia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Desmopressin.
Nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.The pathophysiology of nocturia is multifactorial and can be complex.
It had 1 arm (groups): Desmopressin (experimental).
The registry classes the interventions as drug.
More on the Plan
Measurements * 3-day frequency-volume charts * sleep questionnaire * body weight, blood and urine analysis,serum sodium monitoring * adverse event.
Who Took Part
103 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Aged ≥18 yr. Nocturia ≥2 voids/night. Nocturnal bladder capacity index (NBCi) \>1.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: neurogenic bladder dysfunction; urge incontinence; uncontrolled hypertension characterized by fluid and/or electrolyte imbalance.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2004-04 with completion listed for 2005-12.
It ran at 6 sites in South Korea (6).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 4 secondary outcomes, for example Change in the mean number of nocturnal voids, Change in the mean duration of the period from bedtime to the first nocturnal void, Change in the proportion of patients that felt they had a good sleep experience and Body weight gain.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Desmopressin in 103 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.