Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
NCT ID: NCT01439997
Last Updated: 2022-12-15
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
5 participants
INTERVENTIONAL
2012-03-26
2015-02-01
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?
The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.
There are two groups of patients:
Group A:
Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).
Group B:
This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.
The study starts when the patients takes his first prescribed Minirin Melt tablet:
* On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
* On day 3 the patient has to give a urine sample.
* Patients have to fill out a frequency/volume chart during the first 14 days.
* On day 30, a 3rd blood sample will be taken
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Desmopressin Melt Therapy in Nocturnal Polyuria Patients
Desmopressin
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Interventions
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Desmopressin
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
* evidence for nocturnal polyuria (nocturnal urine volume \>33% of total volume over 24h), determined on frequency/volume chart
* Diuresis \<2.5L
Exclusion Criteria
* pregnancy
* genitourinary tract pathology (infection, tumor,...)
* urolithiasis
* suspicion or evidence of cardiac failure
* moderate to severe renal insufficiency (creatinin clearance \< 60 ml/min)
* psychogenic or habitual polydipsia
* hyponatraemia or predisposition for hyponatraemia
* diabetes insipidus
* syndrome of inadequate ADH production
* suspicion or evidence of liver failure
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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2011/567
Identifier Type: -
Identifier Source: org_study_id