Desmopressin melt therapy in nocturnal polyuria patients: pharmacokinetic/dynamic study

Conditions: octuria and noctural polyuria
Therapeutic area: Body processes [G] - Biological Phenomena [G16]
MedDRA version: 14.0Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 10038359 - Renal and urinary disorders

Registration Number: EUCTR2011-004540-22-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

Inclusion Criteria

- 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) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- 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 the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt in nocturia patients ;Secondary Objective: To determine the reduction of the urine production;Primary end point(s): Blood levels of desmopressin;Timepoint(s) of evaluation of this end point: After 1,2,3,6 and 12 hours of intake of desmopressin melt

Secondary Outcome Measures