Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004560-29-BE

Enrollment

Registered

2011-09-14

Start date

2011-10-25

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noctural polyuria MedDRA version: 14.1 Level: LLT Classification code 10064016 Term: Nocturnal polyuria System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Minirin Melt 60 µg lyophilisaat voor oraal gebruik Product Name: Desmopressin Pharmaceutical Form: Oral lyophilisate INN or Proposed INN: DESMOPRESSIN ACETATE CAS Number: 62357-86-2 Concen

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 - Evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart - Diuresis =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 - suspicion or evidence of liver failure - moderate to severe renal insufficiency (creatinin clearance < 60 ml/min) - psychogenic or habitual polydipsia - hyponatriemia or predisposition for hyponatriemia (sodium < 135 mmol/L) before inclusion - diabetes insipidus - syndrome of inadequate ADH production

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the pharmacodynamic (PD) characteristics of desmopressin melt in nocturia patients;Secondary Objective: Safety;Primary end point(s): Urine production;Timepoint(s) of evaluation of this end point: Everyday during the first fourteen days	—

Secondary

Measure	Time frame
Secondary end point(s): Blood analysis for safety profile ;Timepoint(s) of evaluation of this end point: On day 3, 7 and 30 after the start of the treatment with desmopressin melt	—

Countries

Belgium

Contacts

Public ContactTrial Bureau

Ghent University Hospital

Trialbureau@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026