Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
NCT ID: NCT01435083
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2011-11-30
2013-07-31
Brief Summary
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* Are differences related to the pathophysiological factors involved in nocturia?
* Are there age/gender/size differences?
* Can the investigators identify patients who are likely to develop hyponatraemia?
* Can the investigators individualize treatment and reduce risk for hyponatraemia?
Day 1:
* Patient is being hospitalized in the morning
* General anamnesis and clinical examination
* Uroflow and residue measurements (3x)
* Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin
Day 1-2:
\- In the evening at 20h:
* start (with empty bladder!) 24h miction-incontinence-residue 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: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
* Measurement of blood pressure during 24h
Day 2-3:
* In the evening at 19h (day 2): drink 15mL/kg water
* At 20h: take desmopressin melt 120µg + start:
* 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)
* Measurement of blood pressure during 24h
* Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake
* Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile)
* At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h
* Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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nocturnal polyuria patient with desmopressin MELT
Desmopressin
120 µg, oral lyophilisate, sublingual use
Interventions
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Desmopressin
120 µg, oral lyophilisate, sublingual use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients, men and woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence.
Exclusion Criteria
* pregnancy
* genitourinary tract pathology (infection, tumor,...)
* urolithiasis
* suspicion or evidence of cardiac failure
* moderate to severe renal insufficiency (creatinin clearance \< 50 ml/min)
* psychogenic or habitual polydipsia
* hyponatraemia or predisposition for hyponatraemia
* diabetes insipidus
* syndrome of inadequate ADH production
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Karel Everaert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2011/566
Identifier Type: -
Identifier Source: org_study_id