Characteristics of adult patients with nocturia and nocturnal polyuria and analysis of pharmacokinetic and –dynamic characteristics of desmopressin Melt in this populatio
- Conditions
- octuria and nocturnal polyuria
- Registration Number
- EUCTR2011-000527-33-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Written informed consent prior to the performance of any study-related activity
- Patients 18 years and older with an average of = 2 nocturnal voids per night
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
- pregnancy
- genito-urinary 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
- hyponatriemia or predisposition for hyponatriemia
- diabetes insipidus
- syndrome of inadequate ADH production
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine how 120 µg desmopressin in melt-form is taken up in the blood (=pharmacokinetic characteristics);Secondary Objective: - To correlate the pharmacokinetic characteristics (blood levels) with the pharmacodynamic characteristics (= action of desmopressin = urine production, concentrating capacity)<br>- To see what the influence is of desmopressin melt on the complaint of nocturia (getting up at night, urine production, sleep)<br>- To register side effects, and see if these side effects can be correlated to blood levels and urine results <br>;Primary end point(s): Urine production, concentrating capacity of desmopressin Melt
- Secondary Outcome Measures
Name Time Method