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Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
Plain-language guide to NCT01439997: phase 4 interventional trial of Desmopressin, 5 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01439997
- Phase
- phase 4
- Status
- completed
- Start
- 2012-03-26
- Completion (planned or actual)
- 2013-02-01
- Participants
- 5 (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.
It had 1 arm (groups): Desmopressin Melt Therapy in Nocturnal Polyuria Patients (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 5 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: Written informed consent prior to the performance of any study-related activity. Patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night.
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances; genitourinary tract pathology (infection, tumor,...); suspicion or evidence of cardiac failure.
How the Study Was Run
It was run as a single-group and open-label study.
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 2012-03-26 with completion listed for 2013-02-01.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3 (time frame: At day 3 after first desmopressin intake). Urine sample for urine concentration of Na+, K+, creatinin and osmolality (time frame: At day 3). Area Under Curve (AUC) frequency/volume chart during the first 14 days (time frame: Every day during the first 14 days).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Desmopressin in 5 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.