Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Condition(s) targeted: Nocturnal Polyuria

Intervention: Desmopressin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Karel Everaert, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent

Overall contact:
An-Sofie Goessaert, MD, Email: ansofie.goessaert@ugent.be

The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:

- Are differences related to the pathophysiological factors involved in nocturia?

- Are there age/gender/size differences?

- Can the investigators identify patients who are likely to develop hyponatraemia?

- Can the investigators individualize treatment and reduce risk for hyponatraemia?

Day 1:

- Patient is being hospitalized in the morning

- General anamnesis and clinical examination

- Uroflow and residue measurements (3x)

- Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and

creatinin

Day 1-2:

- In the evening at 20h:

- start (with empty bladder!) 24h miction-incontinence-residue registration: urine

collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin

- Measurement of blood pressure during 24h

Day 2-3:

- In the evening at 19h (day 2): drink 15mL/kg water

- At 20h: take desmopressin melt 120µg + start:

- 24h miction-incontinence-residue registration: registration of volumes and

measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)

- Measurement of blood pressure during 24h

- Collection of urine: U1 at 19h, U2 at 20h, together with intake of first

desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake

- Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin

melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile)

- At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour

during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h

- Patient can go home on day 3, unless he is at high risk for side effects, high-risk

patients are hospitalized for 7 days

Official title: Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults

Secondary outcome:

24h miction-incontinence-residue registration: urine collections every 3 hours

Measurement of blood pressure during 24h

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- written informed consent prior to the performance of any study-related activity

- patients, men and woman, 18 years and older, with nocturnal polyuria, resulting in

nocturia (2 voids or more at night) and/or nocturnal incontinence.

Exclusion Criteria:

- hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances

- pregnancy

- genitourinary 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

- hyponatraemia or predisposition for hyponatraemia

- diabetes insipidus

- syndrome of inadequate ADH production

An-Sofie Goessaert, MD, Email: ansofie.goessaert@ugent.be

University Hospital Ghent, Ghent 9000, Belgium; Recruiting
Karel Everaert, MD, PhD, Email: karel.everaert@uzgent.be
Karel Everaert, MD, PhD, Principal Investigator
An-Sofie Goessaert, MD, Sub-Investigator
Johan Vande Walle, MD, PhD, Sub-Investigator

Related Info

Starting date: November 2011
Last updated: February 1, 2013