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

G

Ghent University Hospital (UZ)

Status and phase

Completed
Phase 4

Conditions

Nocturnal Polyuria

Treatments

Drug: Desmopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT01435083
2011/566

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

nocturnal polyuria patient with desmopressin MELT
Experimental group
Treatment:
Drug: Desmopressin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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