Nocturia and noctural polyuria MedDRA version: 14.0 Level: LLT Classification code 10064016 Term: Nocturnal polyuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Minirin Melt 120 µg
Product Name: Desmopressin
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: DESMOPRESSIN ACETATE
CAS Number: 62357-86-2
Concentration unit: µg microgram(s)
C
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Urine production;Timepoint(s) of evaluation of this end point: After 1,2,3,6 and 12 hours of intake of desmopressin melt | — |
Countries
Belgium
Contacts
Public ContactTrial Bureau
Ghent University Hospital
Outcome results
None listed