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The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:
Day 1:
Day 1-2:
- In the evening at 20h:
Day 2-3:
In the evening at 19h (day 2): drink 15mL/kg water
At 20h: take desmopressin melt 120µg + start:
Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nocturnal polyuria patient with desmopressin MELT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug | 120 µg, oral lyophilisate, sublingual use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults |
| hospitalisation of 3 days of which 15h specific for primary outcome measurements |
| Measure | Description | Time Frame |
|---|---|---|
| 24h miction-incontinence-residue registration: urine collections every 3 hours | 24h miction-incontinence-residu registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with:
| 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karel Everaert, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| Measurement of blood pressure during 24h | 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |