Characteristics of adult patients with nocturia and nocturnal polyuria and analysis of pharmacokinetic and –dynamic characteristics of desmopressin Melt in this population

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000527-33-BE

Enrollment

Unknown

Registered

2011-02-23

Start date

2011-03-21

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Nocturia and nocturnal polyuria

Interventions

Trade Name: Minirin Melt 120 µg Product Name: Desmopressine Pharmaceutical Form: Oral lyophilisate INN or Proposed INN: DESMOPRESSIN ACETATE CAS Number: 62357862 Concentration unit: µg microgram(s) Co

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) 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

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 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) - To see what the influence is of desmopressin melt on the complaint of nocturia (getting up at night, urine production, sleep) - To register side effects, and see if these side effects can be correlated to blood levels and urine results ;Primary end point(s): Urine production, concentrating capacity of desmopressin Melt	—

Measure

Time frame

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) - To see what the influence is of desmopressin melt on the complaint of nocturia (getting up at night, urine production, sleep) - To register side effects, and see if these side effects can be correlated to blood levels and urine results ;Primary end point(s): Urine production, concentrating capacity of desmopressin Melt

—

Countries

Belgium

Outcome results

None listed

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